EXPERT Tibial Nail.

Surgical technique

EXPERT Nailing System

Table of contents
AO/ASIF Principles of internal xation Indications Cases Surgical technique Weight-bearing Implant removal Implants Instruments

Image intensier control

Warning This description is not sufcient for immediate application of the instrumentation. Instruction by a surgeon experienced in handling this instrumentation is highly recommended. Cleaning of instruments: For detailed information please refer to Reprocessing, Care and Maintenance of Synthes Instruments, Article No. 035.000.090.

Synthes

Expert Tibial Nail Surgical technique

Expert Tibial Nail

Advanced solutions Advanced proximal locking options: Three unique and innovative locking options, in combination with Cancellous Bone Locking Screws, for optimised stabilization of the proximal fragment Two state of the art medio-lateral (ML) locking options enable primary compression or secondary controlled dynamisation
Improved stability End Caps: Possibility to block one oblique locking screw with the end cap for absolute angular stability End cap prevents ingrowth of tissue and facilitates nail extraction Self-holding Stardrive recess for effortless and secure end cap pick-up
with hexa lo bul ar ws re in sc
e accordin gt driv al o E rn te

e Synthes lo ck s om i

Stardrive T40

64 106

Advanced nail design: New anatomic bend for facilitated nail insertion and extraction Titanium alloy TAN for improved mechanical and fatigue properties Cannulated nails (from 8 mm to 13 mm) for reamed or unreamed techniques, enabling nail insertion over guide wire Solid nails (from 8 mm to 10 mm) for unreamed technique
Advanced distal locking options: One oblique locking option, placed very distally allowing optimised bone purchase and preventing damages of soft tissues Two ML and one antero-posterior (AP) locking options for better stabilization of the distal fragment
Multidirectional locking options for improved stability All Locking Screws: Double thread for more contact points leading to enhanced stability Thread closer to screw head providing better bone purchase and improved stability Titanium alloy TAN for improved mechanical and fatigue properties Self-holding Stardrive recess for effortless and secure locking screw pick-up Cancellous Bone Locking Screws: In combination with the three innovative and unique proximal locking options of all Tibial Nails Dual core design for optimised purchase in cancellous bone Monocortical Standard Locking Screws: Larger cross section for improved mechanical resistance 4.0 mm for 8 mm and 9 mm Tibial Nails 5.0 mm for 10 mm to 13 mm Tibial Nails

Stardrive T25

AO/ASIF Principles of internal xation
In 1958, the AO/ASIF (Association for the Study of Internal Fixation) formulated four basic principles1, which have become the guidelines for internal xation in general, and intramedullary nailing in particular: Anatomic reduction Before insert the nail the reduction can be achieved manually, using a reduction table, an external xator or a distractor. A guide wire marks the prescribed path into the intramedullary canal and secures alignment of the fragments while the cannulated nail is being inserted over the wire (solid nail design will not allow this procedure). The nail insertion is generally monitored using x-rays. The nail is then locked proximally and distally to the bone fragments in order to hold the reduction. Stable xation Intramedullary nail act as an internal splint that controls but does not prevent micromovements of the fragments. It provides a relative stability that leads to an indirect healing through callus formation. The nails and the locking screws are available in different diameters that allow the surgeon to optimize stability. The judicious choice of locking options (number, position and direction) in the proximal and distal parts of the nail further improves the stability of the implant construct to the bone. Preservation of blood supply When the canal is not reamed, intramedullary nailing generates minimal trauma to the soft tissue and, therefore, the blood supply is maximised through the uninjured endosteum and periosteum. Reaming the canal temporarily disrupts the endosteal blood supply but probably stimulates the revascularization and therefore the bone healing. Early mobilisation Intramedullary nailing, combined with AO technique, provides relative stable fracture xation with minimal trauma to vascular supply. This helps to create an improved environment for bone healing, accelerating the patients return to previous mobility and function.

Reduce fracture Perform closed reduction manually by axial traction under image intensier. The use of the Large Distractor (394.350) or Pinless Fixator (186.310) may be appropriate in certain circumstances. Note: The reduction can be temporarily xed with reduction clamps. In epiphyseal fractures the condyles or the pilon tibiale are xed rst in order to enable the nail insertion.
Determine nail length and diameter
Instruments Radiographic Ruler for Tibial Nails, length 450 mm 03.010.021
The required nail length must be determined after reduction of the lower leg fracture. Position the image intensier as for an AP or lateral x-ray of the proximal tibia (position 1). Using long forceps, hold the Radiographic Ruler parallel to the tibia on the lateral side of the lower leg. Position the ruler such that the end is located at the level of the desired nail insertion point. Mark the skin on the lateral side. Move the image intensier toward the distal end of the tibia (position 2), align the proximal end of the Radiographic Ruler with the skin marking and record an AP x-ray of the distal tibia. Check the reduction and read off the required Tibial Nail length on the Radiographic ruler as it appears in the x-ray. Note: The possibility of compression or dynamisation must be taken into account when determining the Tibial Nail length and a correspondingly shorter nail should be chosen. The Locking Screw in the dynamic locking option can move by up to 7 mm distally. Alternatives Determine the nail length by the above procedure on the uninjured leg or before draping (unsterile) or compare the length of two identical SynReam Reaming Rods 2.5 mm (352.032). Place the Radiographic Ruler over the tibia so that the measuring edge is located over the isthmus. Select the nail diameter (8 mm in this example) shown when the medullary canal/cortex transition is still visible on both sides of the marking. If the reamed technique is used, the diameter of the largest medullary reamer applied must be 0.5 mm to 1.5 mm larger than the nail diameter. Position 2 Position 1
Approach Make an incision in line with the central axis of the intramedullary canal. Depending on the anatomy of the patient, this incision can be transpatellar, medial or even lateral parapatellar. The incision starts proximally at the distal third of the patella along the patellar ligament down to the tibial tuberosity. Mobilise the infrapatellar corpus adiposum laterally and dorsally without opening the synovia. A free access of the nail to the insertion point must be guaranteed. Prepare the entry site of the nail on the ventral edge of the tibial plateau.
Determine entry point The entry point is determinant for the optimal nal position of the Expert Tibial Nail in the intramedullary canal. This is mostly important for proximal and distal metaphyseal fractures regarding fragment non-displacement. In AP view the entry point is in line with the axis of the intramedullary canal and with the lateral tubercle of the intercondylar eminence. In lateral view the entry point is at the ventral edge of the tibial plateau.

Insert guide wire

Instruments Guide Wire 3.2 mm Universal Chuck with T-Handle 357.399 393.100
Secure the Guide Wire in the Universal Chuck and slightly punch mark the insertion point at a 10 angle to the shaft axis in lateral view. Hold a sterile Expert Tibial Nail on the lateral side of the lower leg with its distal end parallel to the tibia shaft. The curved proximal nail end determines the denitive angle of insertion for the Guide Wire. Insert the Guide Wire for approx. 810 cm and check the position under the image intensier in AP and lateral views.
Open medullary canal cutter
Instruments Guide Wire 3.2 mm Cutter for Tibial Nails, 12.0 mm, length 350 mm Protection Sleeve 14.0/12.0, length 161 mm 357.399 03.010.008 03.010.035
Push the Protection Sleeve and the Cutter over the Guide Wire and open the medullary canal over 810 cm. The Guide Wire and the Cutter should not touch the posterior cortex. Remove Guide Wire, Cutter and Protection Sleeve.
Open medullary canal drill bit
Alternative instruments Guide Wire 3.2 mm Drill Bit 12.0 mm, cannulated, length 300 mm, for No. 532.015 Protection Sleeve 14.0/12.0, length 161 mm 357.399 03.010.036 03.010.035
Push the Protection Sleeve and the Drill Bit 12.0 mm over the Guide Wire and open the medullary canal over 810 cm. The Guide Wire and the Drill Bit should not touch the posterior cortex. Remove Guide Wire, Drill and Protection Sleeve.

Open medullary canal awl

Alternative instruments Guide Wire 3.2 mm Awl 12.0 mm, cannulated, length 243 mm 357.399 03.010.040
Push the Awl 12.0 mm over the Guide Wire and open the medullary canal over 810 cm. The Awl should not touch the posterior cortex. Remove Guide Wire and Awl.
Reaming medullary canal (optional)
Instruments SynReam Intramedullary Reaming System 189.060
If necessary enlarge the tibia canal with the medullary reamer up to the desired diameter. Check fracture reduction under the image intensier. Inserting the reaming rod Insert the SynReam Reaming Rod 2.5 mm (352.032) in the medullary canal. Reaming Starting with the diameter 8.5 mm, ream the medullary canal in 0.5 mm increments. The Holding Forceps is used to control the rotation of the Reaming Rod. Advance the reamer head with slight forward and backward movements. Do not use force. Continue reaming until the diameter of the canal is 0.51.5 mm larger than the Tibial Nail diameter. If a solid Tibial Nail is used, remove the Reaming Rod before inserting the Tibial Nail. Note: All cannulated Expert Tibial Nails can be inserted over the SynReam Reaming Rod 2.5 (352.032). The tip of the SynReam Reaming Rod must be correctly positioned in the intramedullary canal since it determines the nal distal position of the Expert Tibial Nail.
Mount nail on insertion handle
Instruments Insertion Handle, for Tibial and Femoral Nails Connecting Screw, for Tibial and Femoral Nails Screwdriver, hexagonal with spherical head 8.0 mm 03.010.045 03.010.044 03.010.092

Orient the Insertion Handle anteriorly, and match the notch on the handle to the Tibial Nail.
Place the Connecting Screw into the Insertion Handle and thread it into the proximal nail end using the Screwdriver Hexagonal with Spherical Head. Check that the Connecting Screw is correctly and well tightened to the nail. Do not overtighten.
Alternative instruments (cannulated Expert Tibial Nails only) Tappet for Reaming Rod with Hexagonal Screwdriver 8.0 mm 03.010.093
Use the Tappet for Reaming Rod with Hexagonal Screwdriver 8.0 mm instead of the described Screwdriver.
Insert nail Note: Knee exion of more than 90 is sometimes necessary to insert the Expert Tibial Nail. Using the Insertion Handle, insert the nail into the intramedullary canal. Rotational movements of small amplitude can help. Monitor the nail passage across the fracture, control in two planes to avoid malalignment. Check nal nail position in AP and lateral views. Note: For proximal locking mount the Aiming Arm only when the Tibial Nail has been completely inserted, otherwise the Aiming Arm may loosen during nail insertion.
Optional instruments Connector, for Insertion Handle Hammer, 700 g Hammer Guide, for No. 357.250 (*) Combination Wrench 11 mm Pin Wrench 4.5 mm 03.010.047 03.010.056 357.220 321.160 321.170
If necessary, insert the nail using light hammer blows. Attach the Connector and tighten it to the insertion handle and use the Hammer in the xed mode. If more insertion forces are necessary, attach the Hammer Guide to the Connector and use the Hammer in sliding mode. To obtain the sliding mode of the Hammer, rst loose the nut on the hammer shaft and x it at the position close to the handle. Note: If insertion is not easily possible, you may chose an Expert Tibial Nail with a smaller diameter or enlarge the entry canal by reaming the intramedullary canal to a larger diameter.
(*) Also adapted for No. 03.010.056
Check proximal nail position
Instruments Aiming Arm for Tibial Nail Guide Wire 3.2 mm 03.010.018 357.399
Attach the Aiming Arm and insert a Guide Wire 3.2 mm in the hole as shown in the illustration. The tip of the Guide Wire indicates the exact proximal position of the Tibial Nail. Remove the Aiming Arm unless proximal locking is the next step.
Check proximal nail position under image intensier in lateral view. Notes: The distance between the markings on the Insertion Handle is 5 mm and corresponds to the extensions of the End Caps. This feature can be used for over insertion of the nail or for correcting the nail length. If primary compression or secondary dynamisation are planned, it is recommended to over insert the nail by more than 7 mm, which corresponds to the maximum distance between the positions in static and dynamic modes.

Determine the length of the locking screw
Instruments Depth Gauge for Locking Screws 03.010.072
Measure the Locking Screw length using the Depth Gauge for Locking Screws. Make sure that the hook is just outside the far cortex and that the sleeve is rmly pressed against the near cortex. Control the correct position of the hook of the Depth Gauge in regard to the far cortex of the tibia. Read the measurement on the shaft of the Depth Gauge, which corresponds to the appropriate length of the Locking Screw.
Alternative instruments Direct Measuring Device for Drill Bits, length 145 mm Drill Bit 3.2 mm, calibrated, length 145 mm, 3-ute, with Coupling for RDL Drill Bit 4.2 mm, calibrated, length 145 mm, 3-ute, with Coupling for RDL Drill Bit 3.2 mm, calibrated, length 145 mm, 3-ute, for Quick Coupling Drill Bit 4.2 mm, calibrated, length 145 mm, 3-ute, for Quick Coupling 03.010.106 03.010.100 03.010.101 03.010.102 03.010.103
Stop drilling immediately after both cortices and dissemble the Drill Bit from the AO Radiolucent Drive. Insert the Direct Measuring Device onto the Drill Bit.
Control the correct position of the Drill Bit in regard to the far cortex of the tibia. Read the measurement on the Direct Measuring Device, which corresponds to the appropriate length of the Locking Screw. Note: A correct end position of Drill Bit is important in order to choose the optimal Locking Screw length.

Insert locking screw

Instruments Screwdriver Stardrive, T25, length 330 mm Holding Sleeve, with Locking Device 03.010.107 03.010.112
(b) Insert the Locking Screw with the correct length with the selfholding Screwdriver Stardrive T25, alone or used in combination with the Holding Sleeve. Control the correct position and length of the Locking Screws. Exchange the Locking Screws with the appropriate length if necessary. Note: In the event of diastasis, the backstroke technique can be used after insertion of the second distal Locking Screw. Use the Holding Sleeve as described below: (a) Insert the Holding Sleeve onto the shaft of the Screwdriver and place the tip of the Screwdriver in the recess of the Locking Screw. (b) Push the Holding Sleeve in the direction of the Locking Screw, the sleeve now holds the Locking Screw. (c) Lock the Holding Sleeve by tightening it anticlockwise. (d) Release the Holding Sleeve after insertion of the Locking Screw by loosening it clockwise and pushing backwards.

Using the corresponding Drill Bit ( 3.2 mm for 4.0 mm Locking Screws or 4.2 mm for 5.0 mm Locking Screws), drill through both cortices until the tip of the drill bit just breaks through the far cortex. Just after drilling both cortices, conrm Drill Bit position. Ensure that the Drill Sleeve is pressed rmly to the near cortex and read the measurement from the calibrated Drill Bit at the back of the Drill Sleeve. This measurement corresponds to the appropriate length of the Locking Screw. Remove the Drill Bit and the Drill Sleeve.
Alternative instrument Depth Gauge for Locking Screws 03.010.072
After drilling both cortices, remove the Drill Bit and the Drill Sleeve. Disassemble the Depth Gauge into 2 parts: the sleeve and the slider with hook. Insert the Slider with Hook into the Protection Sleeve. Make sure that the hook is just outside the far cortex and that the Protection Sleeve is rmly pressed against the near cortex. Control the correct position of the hook of the Depth Gauge in regard to the far cortex of the tibia. Read the measurement on the shaft of the Depth Gauge, which corresponds to the appropriate length of the Locking Screw.

Insert Locking Screw

Instruments Screwdriver Stardrive, T25, length 330 mm 03.010.107
Insert a Locking Screw of the measured length with the Screwdriver Stardrive T25 through the Protection Sleeve until the Locking Screw head lies against the near cortex. The tip of the Locking Screw should project beyond the far cortex by no more than 12 mm. Repeat the steps 21a to 23a for the second proximal ML Locking Screw.
Option Especially for proximal metaphyseal fractures or for highly unstable fractures, additional Cancellous Bone Locking Screws with can be used. For locking procedure of Cancellous Bone Locking Screws with refer to Variant B, steps 19b to 25b on pages 30 to 36. Note: Secondary, controlled dynamisation of the Expert Tibial Nail is possible by removing all proximal Locking Screws except of the dynamic locking position.
Compression locking mode (optional) In case of diastasis, compression of the fracture gap can be needed. The Expert Tibial Nail allows a maximum compression of 7 mm. If more compression of the fracture gap is needed, the conventional backstrike technique is recommended. Notes: At that stage of the surgery the Expert Tibial Nail has been locked distally, refer to steps 13 to 18 on pages 18 to 22. One proximal Locking Screw has been introduced in the dynamic locking option (DYNAM), refer to variant A, steps 19a to 23a on pages 23 to 26. This type of locking procedure does not allow secondary dynamisation of the Expert Tibial Nail.

Insert compression screw

Instruments Compression Screw for Tibial Nail, for No. 03.010.044 Screwdriver, hexagonal with spherical head 8.0 mm 03.010.015 03.010.092
Using the Screwdriver 8.0 mm, conrm that the Connecting Screw between the Insertion Handle and the Tibial Nail is well tightened. Insert the Compression Screw into the Connecting Screw with the Screwdriver 8.0 mm until the Compression Screw (see chapter 9, page 14) contacts the Locking Screw. Every further insertion of the Compression Screw pushes the Locking Screw down in the dynamic slot, respectively the distal fragment of the bone will be pulled up against the proximal fragment. Each revolution of the Compression Screw corresponds to a compression of 1 mm (maximum 7 mm).

common peroneal nerve tibial nerve popliteal artery
C-type fractures of the tibial head (optional) Insert two Cannulated Screws under image intensier control according to standard technique. These cannulated screws must not interfere with the nail and must not damage the tibial plateau. Cannulated Screws Using TAN screws is strongly recommended. The following Cannulated Screws can be considered: Cannulated Screws 6.5 mm, TAN, dark blue (408.401408.482) Cannulated Screws 7.0 mm, TAN, light blue (408.151408.223) Cannulated Screws 7.3 mm, TAN, gold (408.830409.950) Insert Expert Tibial Nail Follow the steps of the surgical technique until insertion of the Tibial Nail, refer to steps 1 to 10 on pages 8 to 15.
Using the Screwdriver 8.0 mm (03.010.092), conrm that the Connecting Screw between the Insertion Handle and the Tibial Nail is well tightened. Mount the Aiming Arm to the Insertion Handle as shown in the illustration. Note: Do not exert forces on the Aiming Arm, Protection Sleeve, Drill Sleeves and Drill Bits in order to guarantee a good drilling precision through the proximal locking holes and to avoid breakage of the Drill Bits. Important: The Insertion Handle allows locking of the antegrade locking option of the Lateral Femoral Nail LFN. Do not use this locking option together with the Tibial Nail.
Check proximal nail position (optional)
Instruments Aiming Arm for Tibial Nail (use blue and green marked guide holes) Protection Sleeve 12.0/8.0, length 188 mm Drill Bit 3.2 mm, calibrated, length 340 mm, 3-ute, for Quick Coupling (with blue and gold marking) 03.010.018 03.010.063
Drill Sleeve 8.0/3.2, for No. 03.010.063 (with blue and gold marking) 03.010.064 03.010.060
Insert the Protection Sleeve 12.0/8.0 mm and the Drill Sleeve 8.0/3.2 mm through the oblique guide hole (OBLI 1) of the Aiming Arm. Insert one Drill Bit 3.2 mm through the corresponding guide hole of the Aiming Arm as illustrated. Do not drill until now. Position the image intensier in lateral view and adjust until the Drill Bit and the Protection Sleeve are perfectly aligned. The view obtained when the Drill Bit and the Protection Sleeve are perfectly aligned is exactly perpendicular to the plane formed by the nail and the Insertion Handle and, therefore, almost parallel to the knee joint. The Drill Bit shows the exact position of the rst proximal Cancellous Bone Locking Screw. If necessary, insert the nail more distally. Note: It is important that the Cannulated Screws and the Cancellous Bone Locking Screws do not interfere, and that the Cancellous Bone Locking Screws do not damage the surface of the tibia plateau. Note: Depending on the anatomy of the patients proximal tibia and on the specic situation, the second proximal oblique locking option can be chosen instead of the rst locking option.

Alternative The position of the second oblique locking option can be checked similarly to the above description but using the oblique guide hole (OBLI 2) of the Aiming Arm and corresponding guide hole for the Drill Bit 3.2.
Instruments Protection Sleeve 12.0/8.0, length 188 mm Trocar 3.2 mm, for No. 03.010.063 (with blue and gold marking) 03.010.063 03.010.069 Drill Sleeve 8.0/3.2, for No. 03.010.063 (with blue and gold marking) 03.010.064
Insert the three part trocar combination (Protection Sleeve, corresponding Drill Sleeve and Trocar) through the desired hole for oblique locking options in the Aiming Arm, make stab incision and insert the Trocar to the bone. Remove the Trocar.
Drill and determine the length of the cancellous bone locking screws
Instruments Drill Bit 3.2 mm, calibrated, length 340 mm, 3-ute, for Quick Coupling (with gold and blue markings) 03.010.060
Insert Protection Sleeve and Drill Sleeve further to the near cortex of the tibia, insert the calibrated Drill Bit 3.2 mm and start drilling the near cortex. Stop drilling immediately after penetrating the near cortex.
By orienting the image intensier perpendicular to the Drill Bit one can control the exact position of the tip of the Drill Bit in the oblique direction. Drill further and control the penetration of the Drill Bit. A long Cancellous Bone Locking Screw will achieve better bone purchase and, therefore, a better stabilization, than a shorter Cancellous Bone Locking Screw. Important: Do not perforate the far cortex with the Drill Bit. Make sure not to damage the tibial plateau.
Conrm Drill Bit position after drilling. Ensure that the Drill Sleeve is pressed rmly to the near cortex and read the measurement from the calibrated Drill Bit at the back of the Drill Sleeve. This measurement corresponds to the appropriate length of the Cancellous Bone Locking Screw. Remove the Drill Bit and the Drill Sleeve. Important: To avoid perforation of the far cortex with the Cancellous Bone Locking Screw, it is recommended to choose a Cancellous Bone Locking Screw 5 mm shorter than the measured length.
Insert cancellous bone locking screws
Insert a Cancellous Bone Locking Screw of the appropriate length with the Screwdriver Stardrive T25 through the Protection Sleeve until the Screw head lies against the near cortex. Do not overthighten.
Repeat the same steps as described above for the second Cancellous Bone Locking Screw.
Option Repeat the same steps as described above for the third proximal Cancellous Bone Locking Screw in the AP direction. The position of the Cancellous Bone Locking Screw should be controlled under image intensier to ensure a correct position of the AP Cancellous Bone Locking Screw.
Instruments Screwdriver Stardrive, T40, cannulated, length 300 mm Guide Wire 3.2 mm 03.010.110 357.399

Remove nail

Instruments Hammer, 700 g 03.010.056
Extract the nail by applying gentle blows with the Hammer.
Alternative instruments Extraction Screw for 516.100 Air Pulse For implantation or extraction of intramedullary femoral and tibial nails 03.010.001 516.100
Before removing the nal Locking Screw, screw the Extraction Screw into the nail and tighten it to prevent rotation or displacement of the nail posteriorly below the tibial plateau. Remove the remaining Locking Screw with the Screwdriver Stardrive T25. Attach Air Pulse to the Extraction Screw and extract the Expert Tibial Nail.

Implants

All implants are available in TAN*. Expert Tibial Nails, cannulated Length mm 465 Length mm 465 * Ti-6Al-7Nb 8 mm dark blue 04.004.231 04.004.234 04.004.237 04.004.240 04.004.243 04.004.246 04.004.249 04.004.252 04.004.255 04.004.258 04.004.261 04.004.264 04.004.267 04.004.270 04.004.mm light green 04.004.531 04.004.534 04.004.537 04.004.540 04.004.543 04.004.546 04.004.549 04.004.552 04.004.555 04.004.558 04.004.561 04.004.564 04.004.567 04.004.570 04.004.mm dark blue 04.004.331 04.004.334 04.004.337 04.004.340 04.004.343 04.004.346 04.004.349 04.004.352 04.004.355 04.004.358 04.004.361 04.004.364 04.004.367 04.004.370 04.004.mm light green 04.004.631 04.004.634 04.004.637 04.004.640 04.004.643 04.004.646 04.004.649 04.004.652 04.004.655 04.004.658 04.004.661 04.004.664 04.004.667 04.004.670 04.004.mm light green 04.004.431 04.004.434 04.004.437 04.004.440 04.004.443 04.004.446 04.004.449 04.004.452 04.004.455 04.004.458 04.004.461 04.004.464 04.004.467 04.004.470 04.004.mm light green 04.004.731 04.004.734 04.004.737 04.004.740 04.004.743 04.004.746 04.004.749 04.004.752 04.004.755 04.004.758 04.004.761 04.004.764 04.004.767 04.004.770 04.004.773

8 mm 9 mm

10 mm

11 mm 12 mm 13 mm

Expert Tibial Nails, solid Length mm mm dark blue 04.024.231 04.024.234 04.024.237 04.024.240 04.024.243 04.024.246 04.024.249 04.024.252 04.024.255 04.024.258 04.024.261 04.024.264 04.024.267 04.024.270 04.024.mm dark blue 04.024.331 04.024.334 04.024.337 04.024.340 04.024.343 04.024.346 04.024.349 04.024.352 04.024.355 04.024.358 04.024.361 04.024.364 04.024.367 04.024.370 04.024.mm light green 04.024.431 04.024.434 04.024.437 04.024.440 04.024.443 04.024.446 04.024.449 04.024.452 04.024.455 04.024.458 04.024.461 04.024.464 04.024.467 04.024.470 04.024.473

Locking Screws for Expert Tibial Nail Cancellous Bone Locking Screws 5.0 mm (gold), Drill 3.2 mm Article No. 04.015.520 04.015.525 04.015.530 04.015.535 04.015.540 04.015.545 04.015.550 04.015.555 04.015.560 04.015.565 04.015.570 04.015.575 04.015.580 Length mm 90
Locking Screws 4.0 mm (dark blue), Drill 3.2 mm Article No. 04.005.408 04.005.410 04.005.412 04.005.414 04.005.416 04.005.418 04.005.420 04.005.422 04.005.424 04.005.426 04.005.428 04.005.430 04.005.432 04.005.434 04.005.436 04.005.438 04.005.440 04.005.442 04.005.444 04.005.446 04.005.448 04.005.450 04.005.452 04.005.454 Length mm 62 64
Locking Screws 4.0 mm (dark blue), Drill 3.2 mm Article No. 04.005.456 04.005.458 04.005.460 04.005.462 04.005.464 04.005.466 04.005.468 04.005.470 Length mm 78 80
Locking Screw 5.0 mm (light green), Drill 4.2 mm Article No. 04.005.516 04.005.518 04.005.520 04.005.522 04.005.524 04.005.526 04.005.528 04.005.530 04.005.532 04.005.534 04.005.536 04.005.538 04.005.540 04.005.542 04.005.544 04.005.546 04.005.548 04.005.550 04.005.552 04.005.554 04.005.556 04.005.558 04.005.560 04.005.562 04.005.564 04.005.566 04.005.568 04.005.570 04.005.575 04.005.580 04.005.585 04.005.590 Length mm 95 100
End Caps for Tibial Nails, (gold) Enable angular stable xation of the most proximal oblique locking option. Article No. 04.004.000 04.004.001 04.004.002 04.004.003 Extension (in mm) 10 15
Enable angular stable xation of the second proximal oblique locking option. Article No. 04.004.004 Extension (in mm) 0

Instruments

Standard instrumentation 03.010.021 Radiographic Ruler for Tibial Nail, length 450 mm

357.399

Guide Wire 3.2 mm

393.100

Universal Chuck with T-Handle

03.010.008

Cutter for Tibial Nails, 12.0 mm, length 350 mm

03.010.035

Protection Sleeve 14.0/12.0

03.010.044

Connecting Screw, for Tibial and Femoral Nails

03.010.045

Insertion Handle, for Tibial and Femoral Nails

03.010.092

Screwdriver, hexagonal with spherical head 8.0 mm

03.010.047

Connector, length 141 mm, for Aiming Arm

321.160

Combination Wrench 11 mm

321.170

Pin Wrench 4.5 mm

357.220

Hammer Guide, for No. 357.250 (*)

03.010.056

Combined Hammer, 700 g, can be mounted

357.398

Shaft, hexagonal, 8.0 mm, cannulated, short, length 125 mm
(*) Also suitable for No. 03.010.056

03.010.100

Drill Bit 3.2 mm, length 145 mm, 3-ute, with Coupling for RDL

03.010.101

Drill Bit 4.2 mm, length 145 mm, 3-ute, with Coupling for RDL

03.010.106

Direct Measuring Device for Drill Bits of length 145 mm, for Nos. 03.010.100105

03.010.107

Screwdriver Stardrive, T25, length 330 mm

03.010.112

Holding Sleeve, with Locking Device, for No. 03.010.107

03.010.018

Aiming Arm for Tibial Nail

03.010.063

Protection Sleeve 12.0/8.0, length 188 mm

03.010.064

Drill Sleeve 8.0/3.2, for No. 03.010.063

03.010.065

Drill Sleeve 8.0/4.0, for No. 03.010.063

03.010.069

Trocar 3.2 mm

03.010.070

Trocar 4.0 mm

03.010.060

Drill Bit 3.2 mm, calibrated, length 340 mm, 3-ute, for Quick Coupling

03.010.061

Drill Bit 4.0 mm, calibrated, length 340 mm, 3-ute, for Quick Coupling

03.010.072

Depth Gauge for Locking Screws 18 to 110 mm, for No. 03.010.063

03.010.015

Compression Screw for Tibial Nail, for No. 03.010.044

03.010.110

Screwdriver Stardrive, T40, cannulated, length 300 mm

03.010.000

Extraction Screw for Tibial and Femoral Nails
Radiolucent Instrumentation (Alternative) 03.010.013 Insertion Handle for Tibial Nail, radiolucent, short

03.010.095

Connecting Screw, cannulated, short, for Tibial Nail

03.010.004

Compression Screw for Tibial Nail

03.010.011

Insertion Handle for Tibial Nail, radiolucent, long

03.010.014

Connecting Screw for Tibial Nail, long, for No. 03.010.011

03.010.007

Compression Screw for Tibial Nail, for No. 03.010.014

03.010.010

Aiming Arm for Tibial Nail, radiolucent

357.117

Hammer Guide for DFN, for No. 357.026 (**)

03.010.124

Combined Hammer 500 g, can be mounted
(**) Also suitable for Expert Tibial Nail for No. 03.010.124
Optional Instruments for Standard and Radiolucent Instrumentation 03.010.093 Rod Pusher for Reaming Rod with Hexagonal Screwdriver 8.0 mm

03.010.036

Drill Bit 12.0 mm, cannulated, length 300 mm, for No. 532.015

03.010.040

Awl 12.0 mm, cannulated

03.010.103

Drill Bit 3.2 mm, length 145 mm, 3-ute, for Quick Coupling

03.010.104

Drill Bit 4.2 mm, length 145 mm, 3-ute, for Quick Coupling

03.010.009

Protection Sleeve 12.0/8.0, length 128 mm

03.010.073

Drill Sleeve 8.0/3.2, for No. 03.010.009

03.010.074

Drill Sleeve 8.0/4.2, for No. 03.010.009

03.010.098

Trocar 3.2 mm, for No. 03.010.073

03.010.099

Trocar 4.2 mm, for No. 03.010.074

03.010.122

Drill Bit 3.2 mm, calibrated, length 270 mm, 3-ute, for Quick Coupling

03.010.123

Drill Bit 4.0 mm, calibrated, length 270 mm, 3-ute, for Quick Coupling

03.010.019

Depth Gauge for Locking Screws, measuring range up to 110 mm, for No. 03.010.009

03.010.001

Extraction Screw for Tibial and Femoral Nails, for No. 516.100
Do not use standard instruments together with alternative instruments before contacting your Synthes representative.
VarioCase 68.004.001 Vario Case for Expert Tibial Nails (Titanium Alloy), incl. Locking Screws and End Caps, without Lid, without Contents

68.004.002

Vario Case for Standard Instruments for Expert Tibial Nail, without Lid, without Contents
Power Tools 530.010 530.100 530.280 Power Drive, complete Power Drive Battery Casing

511.300

Radiolucent Drive

Presented by:

LAG Subject to modications.

036.000.380

SE_001078 AA

Stratec Medical

Printed in Switzerland

The Titanium Cannulated Tibial Nail. Expert Nailing System.

Technique Guide

Expert Nailing System

Table of Contents

Introduction
Titanium Cannulated Tibial Nail Expert System AO ASIF Principles of Internal Fixation Indications Clinical Cases

Surgical Technique

Preoperative Planning Opening the Tibia Inserting the Nail Locking Options Distal Locking Proximal Locking End Cap Insertion Implant Removal

Product Information

Implant Specifications Implants Instruments Set Lists Sterilization Parameters Optional Instruments

Image intensier control

Synthes
Titanium Cannulated Tibial Nail Expert System

Advanced solutions

Advanced proximal locking options Three innovative locking options, in combination with Dual Core Locking Screws, to increase the stability of the proximal fragment for proximal third fractures Two state-of-the-art mediolateral (ML) locking options enable primary compression or secondary controlled dynamization

Improved stability

End Caps Gold end caps securely lock the most proximal oblique locking screw to create a fixed-angle construct Gray end caps feature a lead-in design for easier end cap insertion End caps prevent ingrowth of tissue and facilitates nail extraction Self-retaining T40 StarDrive recess for easy pick up and insertion of end cap Cannulated 0 mm end caps sit flush with nail 5, 10 and 15 mm end caps extend nail height if nail is overinserted
h he xalobu s wit lar ew int scr e

e driv al rn

som e S ynthes l oc has kin

StarDrive T40

acco rding to E NI SO

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Synthes Titanium Cannulated Tibial Nail Expert System
Advanced nail design New anatomic bend for ease of nail insertion Titanium alloy* for improved mechanical and fatigue properties Cannulated nails (from 8 mm to 13 mm dia.) for reamed or unreamed techniques, enabling nail insertion over guide wire All Synthes 2.5 mm or 3.0 mm ball tipped guide wires may be removed through the nail and insertion handle assembly (no exchange tube required)
Advanced distal locking options Distal oblique locking options to prevent soft tissue damage and increase stability of the distal fragment Two ML and one anteroposterior (AP) locking options for stability of the distal fragment
Multidirectional locking options for improved stability
All Locking Screws: Double-lead thread for more contact points enhance stability and ease of insertion Thread closer to screw head provides better bone purchase in the near cortex and improved stability Titanium alloy* for improved mechanical and fatigue properties Self-tapping blunt tip Self-retaining T25 StarDrive recess allows improved torque transmission and increased resistance to stripping relative to a hex recess and secure locking screw pick-up
Dual-Core Locking Screws: Indicated for the three proximal locking options of all tibial nails Dual-core design for optimized purchase in cancellous bone Unicortical Lengths: 30 mm90 mm Standard Locking Screws: Larger cross section for improved mechanical resistance 4.0 mm diameter for 8 mm and 9 mm tibial nails, lengths: 18 mm80 mm 5.0 mm diameter for 10 mm to 13 mm tibial nails, lengths: 26 mm100 mm

StarDrive T25

* Titanium-6% aluminum-7% niobium alloy
AO ASIF Principles of Internal Fixation
In 1958, the AO ASIF (Association for the Study of Internal Fixation) formulated four basic principles,1 which have become the guidelines for internal fixation in general, and intramedullary nailing in particular. Anatomic reduction The Tibial NailEX is designed to fit anatomically in the medullary canal, allowing indirection reduction. Stable fixation The intramedullary nail acts as an internal splint that controls but does not prevent micromovements of the fragments. It provides relative stability that leads to an indirect healing through callus formation. Preservation of blood supply The instruments and implants in the Tibial Nail Expert System permit a percutaneous technique and less tissue stripping than other treatment methods. An intramedullary approach results in decreased blood loss compared to plate fixation. Early mobilization The Tibial NailEX provides secure fixation which permits controlled, early, active rehabilitation conducive to optimal recovery.

Position the patient Position the patient supine on the radiolucent table. Ensure that the knee of the injured leg can be exed at least 90. Position the image intensier so that visualization of the tibia, including the articular surface proximally and distally, is possible in AP and lateral views.
Optionally, the procedure can be performed on a fracture table with the leg placed in traction. Note: The knee roll can be placed under the lower part of the thigh if it obstructs the view of the tibial plateau in the AP view.
Reduce fracture Instrument 394.35 Large Distractor
Perform closed reduction manually by axial traction under image intensication. The use of the Large Distractor may be appropriate in certain circumstances. Note: The reduction can be temporarily fixed with reduction clamps. In epiphyseal fractures the condyles or the pilon are fixed first in order to enable the nail insertion.
Opening the Tibia continued
Confirm nail length and diameter Instrument 03.010.021 Radiographic Ruler for Titanium Cannulated Tibial NailsEX
The required nail length must be determined after reduction of the lower leg fracture. Position the C-arm for an AP view of the distal tibia. With long forceps, hold the Radiographic Ruler along the leg, parallel to and at the same level as the tibia. Adjust the ruler until the distal tip is at the level of the physeal scar or the desired nail insertion depth. Mark the skin at that site. Move the C-arm to the proximal tibia, replace the distal end of the ruler at the skin mark, and take an AP image of the proximal tibia. Read nail length directly from the ruler image, selecting the measurement at or just below the level of the anterior edge of the tibial plateau. When using the Large Distractor, measure the distance from the inferior border of the distal pin to the superior border of the proximal pin to determine optimal nail length. Position the C-arm for an AP or lateral view of the tibia at the level of the isthmus. Hold the Radiographic Ruler over the tibia so that the diameter gauge is centered over the narrowest part of the medullary canal. Read the diameter measurement on the circular indicator that fills the canal. Note: Compression or dynamization must be taken into account when determining the nail length. A shorter nail should be chosen when active compression is planned for the procedure. The dynamic locking option allows for 7 mm of travel. Important: The ruler is not at the same level as the tibia. This affects the accuracy of the measurement, providing only an estimate of the canal diameter.

Approach Make an incision in line with the central axis of the intra-medullary canal. Depending on the anatomy of the patient, this incision can be transpatellar, medial or even lateral parapatellar. The incision starts proximally at the distal third of the patella along the patellar ligament down to the tibial tuberosity. Mobilize the infrapatellar corpus adiposum laterally and dorsally without opening the synovia. Free access of the nail to the insertion point must be guaranteed. Prepare the entry site of the nail on the ventral edge of the tibial plateau.
Determine entry point The entry point defines the optimal position of the nail in the intramedullary canal. This is more important for proximal and distal-third fractures to prevent fragment displacement. In AP view the entry point is in line with the axis of the intramedullary canal and with the lateral tubercle of the intercondylar eminence. In lateral view the entry point is at the ventral edge of the tibial plateau.
Insert guide wire Instrument 357.399 3.2 mm Guide Wire, 400 mm
Slightly punch mark the insertion point at a 10 angle to the shaft axis in the lateral view. Hold a sterile nail on the side of the lower leg with its distal end parallel to the tibia shaft. The curved proximal nail end determines the angle of insertion for the Guide Wire. Insert the Guide Wire for approximately cm and check the position under image intensification in the AP and lateral views.
Open medullary canaldrill bit Instruments 03.010.035 03.010.036 357.399 12.0 mm Protection Sleeve 12.0 mm Cannulated Drill Bit, large quick coupling, 190 mm 3.2 mm Guide Wire, 400 mm
Place the Protection Sleeve and the Drill Bit over the Guide Wire and down to the bone. Drill to a depth of approximately 810 cm. The Guide Wire and the Drill Bit should not touch the posterior cortex. Remove the Guide Wire, Drill Bit and Protection Sleeve. Note: Dispose of the Guide Wire. Do not reuse.
Alternative Instruments 03.010.040 357.399 12.0 mm Cannulated Awl 3.2 mm Guide Wire, 400 mm
Place the Cannulated Awl over the Guide Wire and open the medullary canal. Use a twisting motion to advance the Awl to a depth of approximately cm. The Awl should not touch the posterior cortex. Remove the Guide Wire and Awl. Note: Dispose of the Guide Wire. Do not reuse.

Locking Holes

For use with Dual Core Locking Screws
14 mm Proximal Oblique Distal Oblique
36 mm 57 mm Dynamic Stat 2 Stat mm

AP View

ML View

37 mm 22 mm ML 13 mm

For anterolateral or anteromedial locking (30 to the sagittal plane)
20 Synthes Titanium Cannulated Tibial Nail Expert System

Oblique

Distal Locking
Distal locking Instruments 03.010.006 03.010.017 511.30 Cannulated Connecting Screw Tibial NailEX Insertion Handle Radiolucent Drive
Use the appropriate locking screws and drill bit for the nail diameter selected. Nail Diameter 8 mm and 9 mm (blue) 10 mm to 13 mm (green) Locking Screw 4.0 mm (blue) 5.0 mm (green) Drill Bit 3.2 mm 03.010.100* or 03.010.103 4.2 mm 03.010.101* or 03.010.104
It is recommended to lock distally first, enabling the use of the backstroke technique** to prevent loss of reduction. Verify the nail has been inserted to the appropriate depth. Locking of the Tibial Nail is usually performed from the medial side, if possible with the leg extended. This position helps counteract the forces exerted by the quadriceps muscle that would tend to deform the proximal fragment and also facilitates rotational control of the tibial axis before locking. Note: When locking in extension use Tibial NailEX Insertion Handle and the corresponding connecting screw. Distal locking with the Radiolucent Drive is described on pages 22 and 23. Note: The use of the most distal locking option is recommended for distal fractures. This locking option is oriented 30 from the sagittal plane.
* For Radiolucent Drive ** See page 26.

Distal Locking continued

Align the image Check the reduction, correct alignment of the fragments, and leg length before locking the Expert Tibial Nail. Align the C-arm with the hole in the nail closest to the fracture until a perfect circle is visible in the center of the screen. (Distal ML hole shown in illustration).
Determine incision point Place a scalpel blade on the skin over the center of the hole to mark the incision point and make a stab incision.
Drill Instruments 03.010.100 03.010.101 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, for Radiolucent Drive 4.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, for Radiolucent Drive
Using the Radiolucent Drive under image intensification, insert the tip of the appropriate drill bit through the incision and down to the bone. Incline the drive so that the tip of the Drill Bit is centered over the locking hole. The Drill Bit should almost completely ll the circle of the locking hole. Hold the Drill Bit in this position and drill through both cortices. Tip: For greater drill bit control, discontinue drill power after perforating the near cortex. Manually guide the drill bit through the nail before resuming power to drill the far cortex.

Alternative Instruments 03.010.103 03.010.104 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm 4.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm
Standard freehand locking technique can be performed without the Radiolucent Drive. Use the appropriate drill bit shown above.
Determine the length of the locking screw Instruments 03.010.100 03.010.101 03.010.103 03.010.104 03.010.106 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, for Radiolucent Drive 4.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, for Radiolucent Drive 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm 4.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm Direct Measuring Device, for Locking Screws to 100 mm, for IM Nails
Stop drilling immediately after both cortices and disassemble the Drill Bit from the Radiolucent Drive. Ensure the correct position of the Drill Bit beyond the far cortex. Place the Direct Measuring Device onto the Drill Bit. Read the graduation of the measuring device at the end of the Drill Bit. This corresponds to the appropriate Locking Screw length. Note: Drill Bit location with respect to the far cortex is critical for measuring the appropriate Locking Screw length.
Alternative Instrument 03.010.072 Depth Gauge, for Locking Screws to 100 mm, for IM Nails
Measure the Locking Screw length using the Depth Gauge for Locking Screws. Ensure the outer sleeve is in contact with the bone and the hook grasps the far cortex. Read the Locking Screw length directly from the Depth Gauge at the back of the outer sleeve.
Insert locking screw Instruments 03.010.107 03.010.112 StarDrive Screwdriver, T25, self-retaining Holding Sleeve with Locking Device
Insert the appropriate length Locking Screw using the T25 StarDrive Screwdriver and the Holding Sleeve with Locking Device, if needed.
Verify Locking Screw length under image intensification. If needed, a second Locking Screw may be inserted using the same technique. Note: In the event of loss of reduction, the backstroke technique* can be used after insertion of the second distal Locking Screw. Alternatively, the Compression Device can be used, refer to page 31.
Use the Holding Sleeve as described below: a Insert the Holding Sleeve onto the shaft of the Screwdriver and place the tip of the Screwdriver in the recess of the Locking Screw. b Push the Holding Sleeve in the direction of the Locking Screw, the sleeve now holds the Locking Screw. c Lock the Holding Sleeve by tightening it counterclockwise. d Release the Holding Sleeve after insertion of the Locking Screw, by loosening it clockwise and pushing backwards.

* Backstroke technique: with the hammer guide attached to the driving cap and insertion handle (see page 16) light, reverse hammer blows may be used to compress the fracture; monitor reduction radiographically.
Proximal LockingDiaphyseal and Distal Segment Fractures
Choose the appropriate locking screws and instruments Use the correct Locking Screw, Drill Sleeve, Trocar and Drill Bit for the selected nail diameter, as shown in the table.

STAT 2

STAT 1
Nail Diameter 8 mm and 9 mm (blue) 10 mm13 mm (green)
Locking Screws 4.0 mm (blue) 5.0 mm (green)
Protection Sleeve 12.0 mm/8.0 mm 03.010.063 12.0 mm/8.0 mm 03.010.063
Drill Sleeve 8.0 mm/3.2 mm 03.010.064 8.0 mm/4.2 mm 03.010.065
Trocar 3.2 mm 03.010.069 4.2 mm 03.010.070
Calibrated Drill Bit 3.2 mm 03.010.060 4.2 mm 03.010.061
Three proximal ML locking options can be targeted using the aiming arm: 1 The dynamic locking option (DYNAM) corresponds to the upper position of the proximal locking slot. This type of locking allows primary compression or secondary, controlled dynamization of the bone fragments. 2 Static 2 (STAT 2) corresponding to the lower position of the proximal locking slot. This type of locking does not allow primary compression or secondary controlled dynamization. 3 Static 1 (STAT 1) corresponding to most distal proximal locking hole.
Proximal LockingDiaphyseal and Distal Segment Fractures continued
Mount the aiming arm Instrument 03.010.052 Aiming Arm for the Titanium Cannulated Tibial NailsEX
Confirm that the nail is securely connected to the Insertion Handle using the 8 mm Ball Hex. Mount the Aiming Arm to the Insertion Handle. Note: Do not exert forces on the Aiming Arm, Protection Sleeve, Drill Sleeves and Drill Bits. These forces may prevent accurate targeting through the proximal locking holes and damage the Drill Bits.
Insert trocar combination Instruments 03.010.063 03.010.064 03.010.065 03.010.069 03.010.070 12.0 mm/8.0 mm Protection Sleeve, 188 mm 8.0 mm/3.2 mm Drill Sleeve, 200 mm (with blue and gold marking) 8.0 mm/4.2 mm Drill Sleeve, 200 mm (with green marking) 3.2 mm Trocar, 210 mm (with blue and gold marking) 4.2 mm Trocar, 210 mm (with green marking)

Insert compression device Instruments 03.010.015 Compression Device for Titanium Cannulated Tibial NailsEX, for use with (03.010.044) and (03.010.045) Ball Hex Screwdriver, 8 mm

03.010.092

Confirm that the nail is securely connected to the Insertion Handle using the 8 mm Ball Hex Screwdriver. Insert the Compression Device through the Connecting Screw and into the nail using the 8 mm Ball Hex Screwdriver. The Compression Device will contact the dynamic Locking Screw. Advance the Compression Device until the fracture gap is reduced. Monitor reduction under image intensification. Each revolution of the Compression Device corresponds to compression of 1 mm (maximum 7 mm).
Proximal LockingCompression Locking Mode (optional) continued
Insert compression device continued Important: Do not overtighten the Compression Device, it may deform the Locking Screw. Note: Compression device cannot be used with Tibial NailEX Insertion Handle (03.010.017) and cannulated Connecting Screw (03.010.006). Compression can be accomplished using the backstroke technique (see page 26).
Monitor fracture Control the fracture gap before, during, and after the compression procedure.
Insert static locking screw Insert second proximal Locking Screw in the most distal hole of the proximal locking options (Static 1). Refer to section Diaphyseal and Distal Segment Fractures on pages 27 to 30. Remove the Compression Device. Additional oblique Dual Core Locking Screws can be inserted if required. Refer to section Proximal Segment Fractures on page 33.
Proximal LockingProximal Segment Fractures
Oblique proximal locking Instruments 03.010.006 03.010.015 03.010.017 Cannulated Connecting Screw Compression Device Tibial Nail EX Insertion Handle
04.004.000 Tibial Nail End Cap 04.004.003 Proximal locking can be performed with the leg in full extension. This neutralizes the deforming forces on proximal fragments caused by the quadriceps mechanism and relieves the pressure on the soft tissue usually associated with tibial nail insertion instruments. This position also facilitates assessment of rotational alignment prior to locking. Use the Dual Core Locking Screws (gold) only in combination with the two oblique proximal locking holes (PROXIMAL OBLIQUE, DISTAL OBLIQUE) and A/P proximal locking hole for all nail diameters. Use the 3.2 mm Drill Bit for the 5.0 mm Dual Core Locking Screws. The Aiming Arm can target all three proximal oblique locking options: 1 The oblique locking option (PROXIMAL OBLIQUE) corresponds to the most proximal locking position. Inserting a Tibial Nail End Cap with this Locking Screw will create a fixed-angle construct. 2 The oblique locking option (Distal Oblique) corresponds to the second proximal locking position. 3 The oblique locking option in anteroposterior direction (A/P) corresponds to the third proximal locking position. Important: Drilling for the oblique proximal locking requires special attention. To avoid lesion of the popliteal artery, the tibial nerve and the common peroneal nerve, as well as damage to the proximal tibiobular joint, drilling must be stopped immediately before penetrating the far cortex.

common peroneal nerve tibial nerve

popliteal artery

Proximal LockingProximal Segment Fractures continued
Oblique proximal locking continued Note: When locking with the leg in full extension it is recommended to use the Tibial NailEX Insertion Handle and Cannulated Connecting Screw to prevent impingement on the patella. These devices are not compatible with the Compression Device.
Mount the aiming arm Instruments 03.010.052 03.010.092 Aiming Arm, for Titanium Cannulated Tibial NailEX Ball Hex Screwdriver, 8 mm
Confirm that the nail is securely connected to the Insertion Handle using the 8 mm Ball Hex Screwdriver. Mount the Aiming Arm to the Insertion Handle as shown in the illustration. Note: Do not exert forces on the Aiming Arm, Protection Sleeve, Drill Sleeves and Drill Bits. These forces may prevent accurate targeting through the proximal locking holes and damage the Drill Bits.
Insert trocar combination Instruments 03.010.063 03.010.064 03.010.069 12.0 mm/8.0 mm Protection Sleeve, 188 mm 8.0 mm/3.2 mm Drill Sleeve, 200 mm (with blue and gold marking) 3.2 mm Trocar, 210 mm (with blue and gold marking)
Insert the three-part trocar combination (Protection Sleeve, corresponding Drill Sleeve and Trocar) through the desired hole for oblique locking options in the Aiming Arm, make a stab incision and insert the Trocar to the bone. Remove the Trocar.
Drill and determine the length of the Dual Core Locking Screws Instrument 03.010.060 3.2 mm Three-Fluted Drill Bit, quick coupling, 330 mm, 100 mm calibration (with blue and gold marking)
Ensure that the Drill Sleeve is pressed firmly to the near cortex. Insert the calibrated Drill Bit and start drilling the near cortex. Stop drilling immediately after penetrating the near cortex. DO NOT penetrate the far cortex.
Drill and determine the length of the Dual Core Locking Screws continued Monitor the position of the Drill Bit with image intensification. This can be done by orienting the image intensifier perpendicular to the Drill Bit. Drill to the desired depth. A long Dual Core Locking Screw will achieve better bone purchase than a shorter Dual Core Locking Screw. Important: Do not perforate the far cortex with the Drill Bit. Do not damage the tibial plateau.
Conrm Drill Bit position after drilling. Ensure that the Drill Sleeve is pressed rmly to the bone and read the measurement from the calibrated Drill Bit at the back of the Drill Sleeve. This measurement indicates the appropriate length of the Dual Core Locking Screw. Remove the Drill Bit and the Drill Sleeve. Important: To avoid perforation of the far cortex with the Dual Core Locking Screw, a Dual Core Locking Screw 5 mm shorter than the measured length is recommended.
Insert Dual Core Locking Screws Instrument 03.010.107 StarDrive Screwdriver, T25, self-retaining
Insert the appropriate 5.0 mm Dual Core Locking Screw through the Protection Sleeve, using the T25 Stardrive Screwdriver. Do not overtighten. Verify locking screw length under image intensification.

Implant Removal continued
Attach Extraction Screw and Hammer Guide Instruments 03.010.107 357.133 357.22 StarDrive Screwdriver, T25, self-retaining Extraction Screw Hammer Guide
Before removing the final Locking Screw, screw the Extraction Screw into the tibial nail and tighten it to prevent rotation or displacement of the nail posteriorly below the tibial plateau. Attach the Hammer Guide to the Extraction Screw. Remove the remaining Locking Screw with the T25 StarDrive Screwdriver.
Remove nail Instrument 03.010.056 Slide/Fixed Hammer, 700 grams
Extract the nail by applying gentle blows with the Hammer.

Implant Specifications

Titanium Cannulated Tibial NailsEX Universal design for the left or right tibia Material: Titanium-6% aluminum-7% niobium alloy Diameters: 8 mm13 mm (1 mm increments) 8 mm10 mm nails have a proximal diameter of 11 mm 11 mm13 mm nails have a proximal diameter consistent with the shaft diameter Colors: 8 mm and 9 mm (blue) use 4.0 mm Titanium Locking Screws (blue) 10 mm13 mm (green) use 5.0 mm Titanium Locking Screws (green) Lengths: 255 mm435 mm (15 mm increments) Cross Section: 8 mm10 mm nails are round 11 mm13 mm nails are fluted
14 mm Proximal Oblique Distal Oblique AP
ML AP 22 mm Oblique 5 mm ML 13 mm

Implants

Titanium Cannulated Tibial NailsEX, sterile* Length (mm) mm dia. dark blue 04.004.231S 04.004.234S 04.004.237S 04.004.240S 04.004.243S 04.004.246S 04.004.249S 04.004.252S 04.004.255S 04.004.258S 04.004.261S 04.004.264S 04.004.267S 9 mm dia. dark blue 04.004.331S 04.004.334S 04.004.337S 04.004.340S 04.004.343S 04.004.346S 04.004.349S 04.004.352S 04.004.355S 04.004.358S 04.004.361S 04.004.364S 04.004.367S 10 mm dia. light green 04.004.431S 04.004.434S 04.004.437S 04.004.440S 04.004.443S 04.004.446S 04.004.449S 04.004.452S 04.004.455S 04.004.458S 04.004.461S 04.004.464S 04.004.467S

Length (mm) 435

11 mm dia. light green 04.004.531S 04.004.534S 04.004.537S 04.004.540S 04.004.543S 04.004.546S 04.004.549S 04.004.552S 04.004.555S 04.004.558S 04.004.561S 04.004.564S 04.004.567S
12 mm dia. light green 04.004.631S 04.004.634S 04.004.637S 04.004.640S 04.004.643S 04.004.646S 04.004.649S 04.004.652S 04.004.655S 04.004.658S 04.004.661S 04.004.664S 04.004.667S
13 mm dia. light green 04.004.731S 04.004.734S 04.004.737S 04.004.740S 04.004.743S 04.004.746S 04.004.749S 04.004.752S 04.004.755S 04.004.758S 04.004.761S 04.004.764S 04.004.767S

8 mm 9 mm

11 mm 12 mm 13 mm
5.0 mm Titanium Dual Core Locking Screws, with T25 StarDrive recess, for IM Nails (gold) Titanium alloy* Lengths: 30 mm90 mm (5 mm increments) Used for proximal locking in the metaphysis (through the 3 most proximal holes) Dual core: smaller core (3.4 mm) for better purchase in cancellous bone, larger core (4.3 mm) to withstand load-bearing from the nail Fully threaded Self-tapping, blunt tip Length (mm) 90

04.015.520 04.015.525 04.015.530 04.015.535 04.015.540 04.015.545 04.015.550 04.015.555 04.015.560 04.015.565 04.015.570 04.015.575 04.015.580
Available nonsterile or sterile-packed. Add S to catalog number to order sterile product. * Titanium-6% aluminum-7% niobium alloy

Implants continued

4.0 mm Titanium Locking Screws , with T25 StarDrive recess, for IM Nails (blue) Titanium alloy* Lengths: 18 mm80 mm (2 mm increments) 3.3 mm core diameter Fully threaded Self-tapping, blunt tip Length (mm) Length (mm) 78 80
04.005.408 04.005.410 04.005.412 04.005.414 04.005.416 04.005.418 04.005.420 04.005.422 04.005.424 04.005.426 04.005.428 04.005.430 04.005.432 04.005.434 04.005.436 04.005.438
04.005.440 04.005.442 04.005.444 04.005.446 04.005.448 04.005.450 04.005.452 04.005.454 04.005.456 04.005.458 04.005.460 04.005.462 04.005.464 04.005.466 04.005.468 04.005.470
5.0 mm Titanium Locking Screws , with T25 StarDrive recess, for IM Nails (light green) Titanium alloy* Lengths: 26 mm80 mm (2 mm increments) 85 mm100 mm (5 mm increments) 4.3 mm core diameter Fully threaded Self-tapping, blunt tip Length (mm) Length (mm) 95 100
04.005.516 04.005.518 04.005.520 04.005.522 04.005.524 04.005.526 04.005.528 04.005.530 04.005.532 04.005.534 04.005.536 04.005.538 04.005.540 04.005.542 04.005.544 04.005.546
04.005.548 04.005.550 04.005.552 04.005.554 04.005.556 04.005.558 04.005.560 04.005.562 04.005.564 04.005.566 04.005.568 04.005.570 04.005.575 04.005.580 04.005.585 04.005.590
Titanium End Caps , with T40 StarDrive recess, for Titanium Tibial NailsEX Titanium alloy* Protect nail threads from tissue ingrowth Cannulated T40 StarDrive recess 0 mm Sits flush with end of nail 5 mm, 10 mm and 15 mm extensions Extend nail height if nail is overinserted Gold Titanium End Caps , with T40 StarDrive recess, for Titanium Tibial NailsEX Securely lock the proximal oblique Dual Core Locking Screw Extension (mm) 10 15
04.004.000 04.004.001 04.004.002 04.004.003
Gray Titanium End Caps , with T40 StarDrive recess, for Titanium Tibial NailsEX Lead-in design for easier end cap insertion Will block the two most proximal oblique locking holes Extension (mm) 10 15

Compression Device, for Titanium Cannulated Tibial NailsEX Radiographic Ruler, for Titanium Cannulated Tibial Nails Radiographic Canal Width Estimator, for IM Nails Holding Device for Guide Wires and Reaming Rods 12.0 mm Protection Sleeve 12.0 mm Cannulated Drill Bit, large quick coupling, 190 mm 12.0 mm Cannulated Awl Cannulated Connecting Screw, for Standard Insertion Handle, 2 ea. Standard Insertion Handle Driving Cap with Handle Adapter Aiming Arm, for Titanium Cannulated Tibial NailsEX Slide/Fixed Hammer, 700 Grams 3.2 mm Three-Fluted Drill Bit, quick coupling, 330 mm, 100 mm calibration, 2 ea. 4.2 mm Three-Fluted Drill Bit, quick coupling, 330 mm, 100 mm calibration, 2 ea. 12.0 mm/8.0 mm Protection Sleeve, 188 mm 8.0 mm/3.2 mm Drill Sleeve, 200 mm 8.0 mm/4.2 mm Drill Sleeve, 200 mm 3.2 mm Trocar, 210 mm 4.2 mm Trocar, 210 mm Depth Gauge, for locking screws to 100 mm, for IM nails Ball Hex Screwdriver, 8 mm Reaming Rod Push Rod, with ball handle Ball Hex Screwdriver, 8 mm Reaming Rod Push Rod, with ball handle
Sterilization Parameters for Sets (01.004.300, 01.004.303 and 01.004.304)
These Synthes sets with all additionally available items, as marked in the cases, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Steam Steam Cycle Prevacuum (Wrapped) Gravity Displacement (Wrapped) Temperature 132135C (270275F) 132135C (270275F) Exposure Time 8 Minutes 22 Minutes
Instruments continued 03.010.103 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, 2 ea. 4.2 mm Three-Fluted Drill Bit, quick coupling, 03.010.mm, 2 ea. 03.010.106 Direct Measuring Device, for locking screws to 100 mm, for IM nails 03.010.107 StarDrive Screwdriver, T25, self-retaining 03.010.110 Cannulated StarDrive Screwdriver, T40, self-retaining 03.010.112 Holding Sleeve, with Locking Device 321.17 4.5 mm Pin Wrench, 120 mm, 2 ea. 321.20 Ratchet Wrench, 11 mm width across flats 357.133 Extraction Screw, for Titanium Femoral and Tibial Nails 357.22 Hammer Guide, for Slide Hammer 357.398 Cannulated Shaft with 8 mm hex, 125 mm 357.399 3.2 mm Guide Wire, 400 mm, 3 ea.
Tibial NailEX Implant Set (01.004.304)
Graphic Case 690.504 Locking Screw Rack for Tibial NailEX Implants Implants Gold Titanium End Caps, with T40 StarDrive recess, for Tibial NailsEX, 2 ea. Extension (mm) 04.004.04.004.04.004.04.004.5.0 mm Titanium Dual Core Locking Screws, with T25 StarDrive recess, for IM Nails, 2 ea. 04.015.520 04.015.525 04.015.530 04.015.535 04.015.540 04.015.545 04.015.550 Length (mm) 60 04.015.555 04.015.560 04.015.565 04.015.570 04.015.575 04.015.580 Length (mm) 85 90

4.0 mm Titanium Locking Screws, with T25 StarDrive recess, for IM Nails, 2 ea. 04.005.416 04.005.418 04.005.420 04.005.422 04.005.424 04.005.426 04.005.428 04.005.430 04.005.432 04.005.434 04.005.436 04.005.438 04.005.440 04.005.442 Length (mm) 04.005.444 04.005.446 04.005.448 04.005.450 04.005.452 04.005.454 04.005.456 04.005.458 04.005.460 04.005.462 04.005.464 04.005.466 04.005.468 04.005.470 Length (mm) 78 80
Implants continued 5.0 mm Titanium Locking Screws, with T25 StarDrive recess, for IM Nails, 2 ea. 04.005.516 04.005.518 04.005.520 04.005.522 04.005.524 04.005.526 04.005.528 04.005.530 04.005.532 04.005.534 04.005.536 04.005.538 04.005.540 04.005.542 319.97 Length (mm) Screw Forceps 04.005.544 04.005.546 04.005.548 04.005.550 04.005.552 04.005.554 04.005.556 04.005.558 04.005.560 04.005.562 04.005.564 04.005.566 04.005.568 04.005.570 Length (mm) 78 80
Also Available Gray Titanium End Caps, with T40 StarDrive recess, for Tibial NailsEX, 2 ea. Extension (mm) 04.004.04.004.04.004.04.004.011 15
Tibial NailEX Instrument and Titanium Implant Set (01.004.300)
01.004.300 consists of: 01.004.303 Tibial NailEX Instrument Set 01.004.304 Tibial NailEX Implant Set

Also Available

Optional Instruments 03.010.006 Cannulated Connecting Screw, for Tibial NailEX Insertion Handle 03.010.017 Tibial NailEX Insertion Handle 03.010.100 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm, for Radiolucent Drive 4.2 mm Three-Fluted Drill Bit, quick coupling, 03.010.mm, for Radiolucent Drive 03.010.119 4.6 mm Cleaning Brush 03.010.120 4.6 mm Cleaning Stylet 03.010.121 Large Hexagonal Screwdriver, 3.5 mm width across flats 150.060 Flexible Reamer Set for IM Nails 314.119 StarDrive Screwdriver Shaft, T25, self-retaining, quick coupling, 165 mm 351.706S 2.5 mm Reaming Rod with ball tip, 950 mm, sterile 351.707S 2.5 mm Reaming Rod with ball tip and extension, 950 mm, sterile 357.408 Cleaning Stylet (3.2 mm) 357.409 Cleaning Brush (3.2 mm) 360.251 7.5 mm Intramedullary Reduction Tool, 460 mm 393.105 Small Universal Chuck with T-Handle 394.35 Large Distractor, complete 399.43 Hammer, 700 grams Power Equipment 511.30 Radiolucent Drive Mark II 511.73 Jacobs Chuck with Key (large) 511.75 Quick Coupling for drill bits 511.761 Large Quick Coupling 511.785 Reduction Drive Unit 511.791 Quick Coupling for Kirschner wires 530.100 Power Drive 530.200 Battery, for Power Drive 530.280 Battery Casing, for Power Drive

Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056

2006 Synthes (USA)

Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

www.synthes.com

Printed in U.S.A. 10/06 J6471-B
Synthes and ASIF are trademarks of Synthes (USA).