Technique Guide. 2.7 mm/3.5 mm LCP Distal Fibula Plates. Part of the Synthes locking compression plate (LCP) system.

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Technique Guide 2.7 mm/3.5 mm LCP Distal Fibula Plates. Part of the Synthes locking compression plate (LCP) system.

Table of Contents Introduction 2.7 mm/3.5 mm LCP Distal Fibula Plates 2 AO Principles 4 Indications 5 Surgical Technique Preparation 6 Reduce Distal Fibula 8 Insert and Position Plate 9 Distal Screw Insertion 10 Shaft Screw Insertion 13 Confirm Reduction and Fixation 15 Implant Removal 16 Product Information Implants 17 Instruments 19 Set List 20 Image intensifier control Synthes

2.7 mm/3.5 mm LCP Distal Fibula Plates. Part of the Synthes locking compression plate (LCP) system. The 2.7 mm/3.5 mm LCP Distal Fibula Plates are part of the Synthes locking compression plate system that merges locking screw technology with conventional plating techniques. The plates are available in stainless steel and titanium and feature an anatomic shape and profile, both distally and along the fibular shaft. The Combi holes in the LCP plate shaft combine a dynamic compression unit (DCU) hole with a locking screw hole. Combi holes provide maximum flexibility with the options of axial compression and locking capability throughout the length of the plate shaft. K -wire holes accept K- wires (up to 2.0 mm) to temporarily fix the plate to the distal fibula, to temporarily reduce articular fragments, and to confirm the location of the plate, relative to the distal fibula. Fixation with the 2.7 mm/3.5 mm LCP Distal Fibula Plates provides the same benefits of traditional plate fixation methods, with a few important improvements. Locking screws provide the ability to create a fixed-angle construct while using standard AO plating techniques. The ability to place locking screws is especially important in osteopenic bone, short bone fragments, and multifragment fractures, where screw purchase is compromised. These screws do not rely on plate- to- bone compression to resist patient load, but function similarly to multiple, small, angled blade plates. 2 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

2.7 mm/3.5 mm LCP Lateral Distal Fibula Plate Five coaxial distal holes accept 2.4 mm and 2.7 mm locking and cortex screws to provide multiple screw options Anatomically shaped Combi holes in shaft accept 3.5 mm locking screws, 3.5 mm cortex screws, and 4.0 mm cancellous bone screws Recesses for screwheads in coaxial holes minimize screw prominence to create a low-profile construct Four K-wire holes in the head accept 2.0 mm K-wires 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plate Six round locking holes and two coaxial holes accept 2.4 mm and 2.7 mm locking and cortex screws to provide multiple screw options Combi holes in shaft accept 3.5 mm locking screws, 3.5 mm cortex screws, and 4.0 mm cancellous bone screws Anatomically shaped Recesses for screwheads in coaxial holes minimize screw prominence to create a low-profile construct Screw profiles in coaxial hole 2.4 mm cortex screw 2.7 mm cortex screw 2.7 mm locking screw Synthes 3

AO Principles In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1 These principles, as applied to the 2.7 mm/3.5 mm LCP Distal Fibula Plates are: Anatomic reduction The anatomic plate profile assists with reduction of the distal fibula to the diaphysis and assessment of length, rotation and alignment of the distal fibula. Multiple distal screws at the distal fibula allow maintenance of the articular reduction and stabilization of the distal segment relative to the fibular shaft. Stable fixation The combination of conventional and locking screws offers optimum fixation regardless of bone density. Preservation of blood supply The anatomic design of the plate minimizes additional insult to the local soft tissues. The proximal plate end is rounded for ease of insertion. The distal plate end is beveled to minimize additional soft tissue damage and local tissue irritation. Early, active mobilization Plate features combined with AO technique create an environment for early bone healing, expediting return to function. 1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991. 4 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Indications The 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies and nonunions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. Synthes 5

Preparation The techniques for implanting the lateral and posterolateral distal fibula plates are similar. The following describes implantation of a lateral plate. 1 Preoperative planning Required set 105.434/ Small Fragment LCP Instrument and Implant 145.434 Set, with self-tapping screws (stainless steel or titanium) Complete the preoperative radiographic assessment and plan. Determine plate length and distal screw locations to ensure proper plate selection and position, and screw placement in the distal fibula. 6 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

2 Position patient Position the patient supine with a sandbag (bump) underneath the buttock of the affected side. This allows the foot to lie in a neutral position and prevents the normal external rotation of the leg. Elevate the leg on a padded rest with the knee slightly flexed to assist placement in a neutral position. Visualization of the distal fibula under fluoroscopy in both the lateral and AP views is recommended. Note: The direction of the locking screws is determined by the design of the plate, based on the average anatomy of the distal fibula. If manual contouring of the plate in the metaphyseal area is necessary, or if the patient s normal anatomy is not well matched by the implant, the distal screw trajectories will be altered. The screw trajectories can be confirmed using the K-wire screw placement verification technique. 3 Approach Make a straight lateral or posterolateral surgical incision to expose the fibular fracture, the distal fibula, and the fibular diaphysis. A lateral incision directly over the fibula can accentuate plate prominence and the wound closure will be directly over the implant. Alternatively, the incision can be placed along the posterolateral border of the fibula where there is improved soft tissue coverage. Be careful not to damage the superficial peroneal nerve proximally and anteriorly, or the sural nerve posteriorly. Deep dissection allows exposure of the fibula along its length. An extraperiosteal approach to the fibula proximal to the fracture is usually preferred. Synthes 7

Reduce Distal Fibula 4 Reduce fibular fracture Expose and clean the fracture site and reduce the fracture. It is critical that fibular length, alignment and rotation are accurately restored. In spiral or oblique fracture patterns, a clamp can be applied for reduction. Provisional reduction can be maintained with pointed reduction forceps or K-wires. Alternatively, in some fracture patterns, the plate can be used to assist with and guide the reduction. This may be especially important in comminuted fractures where a bridging technique is used. Technique tip: Application of an external fixator or distractor may facilitate obtaining fibular length, fracture reduction and visualization of the distal tibiofibular joint. Confirm the reduction with image intensification. Temporary reduction can be obtained with clamps, multiple Kirschner wires, or independent lag screws if the fracture pattern allows. K-wires can be placed through the distal end of the plate to assist with temporary maintenance of the reduction and for plate placement. Options for maintaining the reduction depend on the fracture configuration and include: Independent lag screws Lag screws through the plate Locking screws through the plate Locking screws do not provide interfragmentary compression; compression must be achieved with standard lag screws or by using the plate itself to compress the fracture. The fracture must be reduced and compressed before fixation of the LCP distal fibula plate with locking screws in simple fracture configurations. If a bridge plate technique is planned, the implant can be secured proximally and distally using locking screws, if the fibular length, alignment and rotation are correct. 8 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Insert and Position Plate 5 Insert plate Expose the fibula proximally as needed for plate application. In the majority of circumstances, an open approach for plate application will be performed. Occasionally, a submuscular plate insertion will be performed using a minimally invasive technique. The plate can be slid along the lateral fibular shaft and positioned with the distal end of the plate approximately 5 mm from the tip of the fibula. Note: The 2.7 mm/3.5 mm posterolateral fibula plate is typically positioned 8 10 mm from the tip of the fibula. 6 Position plate and fix provisionally Temporarily hold the plate in position using any of the following options. These options also prevent plate rotation while inserting the first locking screw: Standard plate holding forceps K-wires placed through the plate distally and/ or proximally 2.7 mm cortex screw placed in one of the distal holes 3.5 mm cortex screw placed in a Combi hole After plate insertion, check plate placement and alignment using fluoroscopy. Ensure proper reduction before inserting the first locking screw. Once locking screws are inserted, further reduction is not possible without loosening the locking screws. Verify plate placement under image intensification to determine if final screw and plate placement are acceptable. Synthes 9

Distal Screw Insertion 7 Distal screw insertion Determine the combination of screws to be used for fixation. If a combination of locking and cortex screws will be used, cortex screws should be inserted first. Note: To secure the plate to the fibula before locking screw insertion, it is recommended to pull the plate to the bone using a cortex screw. Nonlocking screw insertion fixation with 2.7 mm cortex screws Instruments 311.43 Handle, with quick coupling 315.28* 2.7 mm Three-Fluted Drill Bit, quick coupling, 125 mm 319.006 Depth Gauge 323.062 2.0 mm Drill Bit with depth mark, quick coupling, 140 mm 323.26* 2.7 mm Universal Drill Guide Use the 2.0 mm drill bit through the 2.7 mm universal drill guide to predrill the bone. Measure for screw length using the depth gauge. Select and insert the appropriate 2.7 mm cortex screw using the small hexagonal screwdriver. * Found in the Small Fragment LCP Instrument and Implant Set 10 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Locking screw insertion If a locking screw will be used as the first screw, be sure the fracture is reduced and the plate is held securely to the bone. This prevents plate rotation as the screw is locked to the plate. Instruments 311.43 Handle, with quick coupling 313.353 Drill Guide 314.467 StarDrive Screwdriver Shaft, T8 314.468* Holding Sleeve for StarDrive Screwdriver Shaft, T8 319.006 Depth Gauge 323.061 2.0 mm Threaded Drill Guide, with Depth Gauge 323.062 2.0 mm Drill Bit with depth mark, quick coupling, 110 mm 511.776 Torque Limiting Attachment, 0.8 Nm, quick coupling Insert the 2.0 mm threaded drill guide into a 2.7 mm locking hole until fully seated. Use the 2.0 mm drill bit to drill to the desired depth. Remove the 2.0 mm threaded drill guide. Use the depth gauge to determine screw length. Note: When determining appropriate screw length, ensure that the screw tip will not protrude past the articular surface. * Also available Synthes 11

Distal Screw Insertion 7. Distal screw insertion Locking screw insertion continued Alternative technique: Direct measuring with calibrated drill bit Determine where locking screws will be used. Screw the 2.0 mm threaded drill guide into a threaded hole until it is fully seated. Use the 2.0 mm drill bit with depth mark to drill to the desired depth. Determine the screw length directly from the 2.0 mm drill bit. The 2.7 mm locking screw can be inserted manually or with power. For power insertion, use the T8 StarDrive screwdriver shaft attached to the 0.8 Nm torque limiting attachment. For manual insertion, use a handle with quick coupling. Use a holding sleeve, if necessary. Insert additional locking screws, as planned. 12 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Shaft Screw Insertion 8 Shaft screw insertion Nonlocking screw insertion fixation with 3.5 mm cortex screws Instruments 310.25* 2.5 mm Drill Bit 310.35* 3.5 mm Drill Bit 311.43 Handle, with quick coupling 314.02* Small Hexagonal Screwdriver with Holding Sleeve or 314.03* Small Hexagonal Screwdriver Shaft 319.01* Depth Gauge 323.36* 3.5 mm Universal Drill Guide Use the 2.5 mm drill bit through the 3.5 mm universal drill guide to predrill the bone. For the neutral position, press the drill guide down in the nonthreaded hole. To obtain compression, place the drill guide at the end of the nonthreaded hole away from the fracture (do not apply downward pressure on the spring-loaded tip). Measure for screw length using the depth gauge for small screws. Select and insert the appropriate 3.5 mm cortex screw using a small hexagonal screwdriver. * Found in the Small Fragment LCP Instrument and Implant Set Synthes 13

Shaft Screw Insertion 8. Shaft screw insertion continued Locking screw insertion Instruments 310.288* 2.8 mm Drill Bit 312.648* 2.8 mm Threaded Drill Guide 314.115* StarDrive Screwdriver, T15 314.116* StarDrive Screwdriver Shaft, T15 319.01* Depth Gauge 511.770** Torque Limiting Attachment, 1.5 Nm or 511.773* Torque Limiting Attachment, 1.5 Nm, quick coupling Insert the 2.8 mm threaded drill guide into a locking hole or Combi hole until fully seated. Use the 2.8 mm drill bit to drill to the desired depth. Remove the drill guide. Use the depth gauge to determine screw length. Insert screw. * Found in the Small Fragment LCP Instrument and Implant Set ** Also available 14 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Confirm Reduction and Fixation 9 Confirm reduction and fixation Carefully assess the final reduction and fixation via direct visualization and image intensification. Confirm the stability of the fixation and that there is unrestricted motion at the ankle joint. Using AP and lateral fluoroscopic visualization, confirm reduction and appropriate positioning of the plate and screws. Synthes 15

Implant Removal Implant removal Optional set 01.240.001 Screw Removal Set Optional instrument 309.520* Conical Extraction Screw Unlock all screws from the plate, then remove the screws completely from the bone. This prevents simultaneous rotation of the plate when unlocking the last locking screw. If the screws cannot be removed with the screwdriver, insert the conical extraction screw with left-handed thread into the screwhead using a handle with quick coupling and loosen the locking screw by turning counterclockwise. * Found in Screw Removal Set 01.240.001 16 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Screws Used with the 2.7 mm/3.5 mm LCP Distal Fibula Plates Stainless Steel and Titanium 4.0 mm Cancellous Bone Screws* May be used in the DCU portion of the Combi holes in the plate shaft Compress the plate to the bone or create axial compression Fully or partially threaded shaft Stainless steel or titanium 3.5 mm Cortex Screws, self-tapping* May be used in the DCU portion of the Combi holes in the plate shaft Compress the plate to the bone or create axial compression Stainless steel or titanium 3.5 mm Locking Screws, self-tapping* Used in the locking portion of the Combi holes in the plate shaft Create a locked, fixed-angle screw/plate construct Stainless steel or titanium alloy 2.7 mm Cortex Screws, self-tapping* May be used in the distal locking holes Compress the plate to the bone Stainless steel or titanium alloy 2.7 mm Locking Screws, self-tapping Used in the distal locking holes Stainless steel or titanium alloy 2.4 mm Cortex Screws, self-tapping** May be used in the distal locking holes Compress the plate to the bone Stainless steel or titanium alloy 2.4 mm Locking Screws, self-tapping** Used in the distal locking holes Stainless steel or titanium alloy Screws available in implant-quality 316L stainless steel, commercially pure (CP) titanium, or titanium alloy (Ti-6AI-7Nb) as noted. * Found in the Small Fragment LCP Instrument and Implant Set ** Found in the Modular Mini Fragment LCP Instrument and Implant Set Synthes 17

Implants 2.7 mm/3.5 mm LCP Lateral Distal Fibula Plates Right and left designs 3 to 11 shaft holes Lengths from 73 mm to 177 mm 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plates Right and left designs 3 to 11 shaft holes Lengths from 77 mm to 181 mm Plates available in implant-quality 22Cr-13Ni-5Mn stainless steel or titanium alloy (Ti-6AI-7Nb). 18 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

Instruments 311.43 Handle with quick coupling 313.353 Drill Sleeve for 2.0 mm Drill Bit 314.467 StarDrive Screwdriver Shaft, T8 319.006 Depth Gauge 323.061 2.0 mm Threaded Drill Guide 323.062 2.0 mm Drill Bit with depth mark 511.776 Torque Limiting Attachment, 0.8 Nm, quick coupling Synthes 19

2.7 mm/3.5 mm LCP Distal Fibula Plate Instrument and Implant Sets Stainless Steel (01.112.077) and Titanium (01.112.080) Graphic Case 60.112.046 Graphic Case, for LCP Distal Fibula Plates 60.112.047 Tray for 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plates Instruments 311.43 Handle, with quick coupling 313.353 Drill Sleeve for 2.0 mm Drill Bit 314.467 StarDrive Screwdriver Shaft, T8 319.006 Depth Gauge, for 2.0 mm and 2.4 mm screws 323.061 2.0 mm Threaded Drill Guide, with depth gauge 323.062 2.0 mm Drill Bit with depth mark, quick coupling, 2 ea. 511.776 Torque Limiting Attachment, 0.8 Nm, quick coupling Implants 2.7 mm/3.5 mm LCP Lateral Distal Fibula Plates Stainless Length Steel Titanium Holes (mm) 02.112.136 04.112.136 3 73 right 02.112.137 04.112.137 3 73 left 02.112.138 04.112.138 4 86 right 02.112.139 04.112.139 4 86 left 02.112.140 04.112.140 5 99 right 02.112.141 04.112.141 5 99 left 02.112.142 04.112.142 6 112 right 02.112.143 04.112.143 6 112 left 02.112.144 04.112.144 7 125 right 02.112.145 04.112.145 7 125 left 02.112.148 04.112.146 9 151 right 02.112.149 04.112.149 9 151 left 02.112.152 04.112.148 11 177 right 02.112.153 04.112.153 11 177 left Posterolateral plates not shown Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://us.synthes.com/medical+community/cleaning+and+sterilization.htm or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ1304 20 Synthes 2.7 mm/ 3.5 mm LCP Distal Fibula Plates Technique Guide

2.7 mm/ 3.5 mm LCP Posterolateral Distal Fibula Plates Stainless Length Steel Titanium Holes (mm) 02.112.106 04.112.106 3 73 right 02.112.107 04.112.107 3 73 left 02.112.108 04.112.108 4 86 right 02.112.109 04.112.109 4 86 left 02.112.110 04.112.110 5 99 right 02.112.111 04.112.111 5 99 left 02.112.112 04.112.112 6 112 right 02.112.113 04.112.113 6 112 left 02.112.114 04.112.114 7 125 right 02.112.115 04.112.115 7 125 left 02.112.118 04.112.118 9 151 right 02.112.119 04.112.119 9 151 left 02.112.122 04.112.122 11 177 right 02.112.123 04.112.123 11 177 left 2.7 mm Locking Screws, self-tapping, with T8 StarDrive recess, 2 ea. Stainless Steel Titanium Length (mm) 202.208 402.208 8 202.210 402.210 10 202.212 402.212 12 202.214 402.214 14 202.216 402.216 16 202.218 402.218 18 202.220 402.220 20 202.222 402.222 22 202.224 402.224 24 202.226 402.226 26 202.228 402.228 28 202.230 402.230 30 Required Set 105.434/ Small Fragment LCP Instrument and Implant 145.434 Set, with self-tapping screws (stainless steel or titanium) Also Available 01.111.120 Modular Mini Fragment LCP Instrument and Implant Set 01.112.042 2.7 mm/ 3.5 mm LCP Lateral Distal Fibula Plate Instrument and Implant Set 01.112.044 2.7 mm/ 3.5 mm Titanium LCP Lateral Distal Fibula Plate Instrument and Implant Set 01.112.075 2.7 mm/ 3.5 mm LCP Posterolateral Distal Fibula Plate Instrument and Implant Set 01.112.078 2.7 mm/ 3.5 mm Titanium LCP Posterolateral Distal Fibula Plate Instrument and Implant Set 01.112.076 2.7 mm/ 3.5 mm LCP Posterolateral Distal Fibula Plate Implant Upgrade Set 01.112.079 2.7 mm/ 3.5 mm Titanium LCP Posterolateral Distal Fibula Plate Implant Upgrade Set 01.240.001 Screw Removal Set 314.468 Holding Sleeve, for StarDrive Screwdriver Shaft, T8 323.36 3.5 mm Universal Drill Guide 511.770 Torque Limiting Attachment, 1.5 Nm 60.112.043 Screw Rack, fo 2.7 mm/3.5 mm LCP Distal Fibula Set Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://us.synthes.com/medical+community/cleaning+and+sterilization.htm or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ1304 Synthes

Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 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 2009 Synthes, Inc. or its affiliates. All rights reserved. Combi, LCP and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/10 J8708-C