Technique Guide. Variable Angle LCP Opening Wedge Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7.

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1 Technique Guide Variable Angle LCP Opening Wedge Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7.

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3 Table of Contents Introduction Variable Angle LCP Opening Wedge Plates 2.4 / Indications 4 Screw Insertion Techniques 5 Surgical Technique Approach 6 Implantation 7 Implant Removal 20 Product Information Screws 21 Plates 23 Instruments 24 Synthes Biomaterials Overview 28 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: Synthes 1

4 Variable Angle LCP Opening Wedge Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7. Features and Benefits Compression wire holes for preliminary fixation of the plate to the bone Variable angle Screw holes allow up to 15 off-axis screw angulation in all directions Minimized soft tissue irritation Low profile plates with rounded edges and highly polished surface minimize soft tissue irritation Spacer includes a tapered tip for easier insertion into the osteotomy site 6 plates with varying spacer lengths: 3 mm, 4 mm, 5 mm, 6 mm and 7 mm One plate without spacer Anatomic, low profile designed specifically for opening wedge osteo - tomies for hallux valgus correction and other foot deformities 2 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

5 Opening Wedge Measuring Instrument Ratchet mechanism holds osteo tomy open Thin tip slides into osteotomy site and opens the wedge for the desired correction Measurement scale indicates the appropriate size wedge for the desired opening Synthes 3

6 Indications The Opening Wedge Plate of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7 is indicated for deformations (e.g. hallux valgus), nonunions, and replantations of the first metatarsal bone, particularly in osteopenic bone. 4 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 mm Technique Guide

7 Screw Insertion Techniques The plate holes of the Variable Angle LCP Technology 2.4 / 2.7 accept 2.4 mm and 2.7 mm Variable Angle (VA) Locking Screws. Screws can be inserted using two different techniques: Variable angle technique Pre-defined nominal angle technique Variable angle technique To drill variable angle holes at a ±15 deviation from the nominal trajectory of the locking hole, insert the tip of the conical VA-LCP drill sleeve ( / ) and key into the cloverleaf design of the VA-LCP hole. VA-LCP drill sleeve, conical, for Drill Bits ( / ) Note: It is important not to angulate more than 15 from the central axis of the screw hole. Overangulation may result in difficulty while locking the screw and inadequate screw locking. Pre-defined nominal angle technique The fixed-angle VA-LCP drill sleeve ( / ) only allows the drill bit to follow the nominal trajectory of the locking hole. Use of funnel-shaped VA-LCP Drill Sleeve VA-LCP Drill Sleeve, coaxial, for Drill Bits ( / ) Synthes 5

8 Approach Make a 3 to 4 cm dorsomedial incision from the first tarsal metatarsal (TMT) joint, distally along the midline of the first metatarsal. Dissect down to the bone and isolate the medial branch of the superficial fibular nerve. 6 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

9 Implantation 1 Create osteotomy Identify a point medial on the metatarsal, approximately 1.5 cm distal to the TMT joint. Create an osteotomy starting from the medial side of the metatarsal but do not cut through the bone. Leave the lateral cortex intact to act as a hinge point for opening the wedge. Synthes 7

10 Implantation 2 Open osteotomy and measure Instrument Opening Wedge Measuring Device Open the osteotomy using osteotomes or the opening wedge measuring device. Slide the tip of the opening wedge device into the osteotomy. Open the osteotomy by squeezing the handle until the desired correction is achieved. The measuring instrument should be placed in the final implant position to ensure correct alignment and measurement. Use image intensifier control to confirm that the desired correction has been achieved. Read the measurement on the back of the instrument to determine the appropriate spacer size. Remove the measuring instrument. 8 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

11 3 Position plate Select the appropriate plate that allows the desired level of correction as measured. Position the plate with the top of the T proximal to the osteotomy. Insert the plate into the osteotomy. The tip of the spacer has a lead-in design to aid in inserting the wedge into the osteo - tomy. A compression wire can be used to hold the plate in position. Synthes 9

12 Implantation 4 Pre-drill for VA locking screws Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm VA-LCP Drill Sleeve 2.7, coaxial, for Drill Bits 2.0 mm Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm VA-LCP Drill Sleeve 2.4, coaxial, for Drill Bits 1.8 mm Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Determine the size of screws to be used, 2.4 or 2.7 mm, and whether they will be inserted at a variable angle (4a) or at the pre-defined nominal angle (4b). 10 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

13 4a Pre-drill using variable angle technique Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Insert and lock the VA-LCP drill sleeve tip into the cloverleaf design of the VA-LCP hole. The cone will self retain in the hole. Synthes 11

14 Implantation Use the 2.0 mm drill bit (2.7 mm VA screw) or the 1.8 mm drill bit (2.4 mm VA screw) to drill at the desired angle and to the desired depth. The cone of the drill sleeve allows the drill bit to be angled up to 15 around the central axis of the locking hole. Important: To ensure that the drill guide is locked correctly, do not angle the drill bit in excess of ±15 from the nominal trajectory of the hole. To achieve the desired angle, verify the drill bit angle and depth under image intensifier control. If incorrect, drill at a different angle and verify again under image intensification. Use the according depth gauge to measure the correct screw length. 12 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

15 4b Pre-drill using pre-defined nominal angle technique Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, coaxial for Drill Bits 2.0 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Optional instrument Universal Drill Guide 2.7 Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110 / 85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, coaxial for Drill Bits 1.8 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Optional instrument Universal Drill Guide 2.4 Variable angle locking screws and standard locking screws can be inserted into the plate at the predefined hole angle or coaxial. Synthes 13

16 Implantation Insert and lock the VA-LCP drill sleeve tip into the cloverleaf design of the VA-LCP hole. The coaxial drill guide will self retain in the hole. Use the 2.0 mm drill bit (for VA locking screw and standard 2.7 mm locking screws) or the 1.8 mm drill bit (for VA locking screw and standard 2.4 mm locking screws) to drill to the desired depth. Verify the drill bit depth under image intensification. Use the according depth gauge to measure the correct screw length. 14 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

17 5 Insert VA locking screws Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Handle with Quick Coupling, length 110 mm or Handle with Quick Coupling Insert the correct length variable angle locking screw manually using the screwdriver shaft and handle with quick coupling. Insert the screw until the screw head is seated (with limited force) in the variable angle locking hole. Important: Do not over-tighten screws. This allows the screws to be easily removed should they not be in the desired position. Insert additional screws as needed. Confirm proper reconstruction, screw placement and screw length under image intensification. Synthes 15

18 Implantation 6 Lock VA locking screws Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling Handle for Torque Limiters 0.4 / 0.8 / 1.2 Nm Use the 1.2 Nm torque limiting attachment (TLA) to perform the final locking step for variable angle locking screws. The torque limiting attachment attaches to the T8 Stardrive screwdriver shaft and the blue handle of the torque limiting attachment. After appropriate screw angle and screw length has been finalized, manually insert the screw using the TLA assembly. Use of the TLA is mandatory for variable angle locking holes to ensure the correct amount of torque is applied when inserting the screws. With this final locking step, the screws are securely locked in the plate to achieve maximum strength of the plate-screw inter face. Remove the compression wires. 16 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

19 7 Optional: Insert cortex screw Instruments cortex screws 2.7 mm Drill Bit 2.0 mm, with marking, length 110 / 85 mm, 2-flute, for Quick Coupling Drill Bit 2.7 mm, length 100 / 75 mm, 2-flute, for Quick Coupling Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Screwdriver Shaft, Stardrive, T8, self-holding Instruments cortex screws 2.4 mm Drill Bit 1.8 mm, with marking, length 110 / 85 mm, 2-flute, for Quick Coupling Drill Bit 2.4 mm, length 100 / 75 mm, 2-flute, for Quick Coupling Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Screwdriver Shaft, Stardrive, T8, self-holding Synthes 17

20 Implantation Determine where 2.4 mm or 2.7 mm cortex screws will be used in the holes of the plate. For 2.4 mm cortex screws, use the 2.4 universal drill guide. Predrill the screw hole with the 1.8 mm drill bit. For 2.7 mm cortex screws, use the 2.7 universal drill guide. Predrill the screw hole with the 2.0 mm drill bit. To drill a gliding hole for compression, use the 2.7 mm drill bit (for 2.7 mm cortex screw) or the 2.4 mm drill bit (for 2.4 mm cortex screw) with the double drill guide. Determine the screw length with the depth gauge and insert the screw. 18 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

21 8 Ensure proper reconstruction Ensure proper joint reconstruction, screw placement and screw length under image intensification. Verify that the screws are not in the soft tissue. Synthes 19

22 Implant Removal Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Handle with Quick Coupling To remove locking screws, first unlock all locking screws before removing them completely. Otherwise, the plate may rotate and damage the soft tissue. 20 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

23 Screws Variable angle locking screws (VA-LCP) 2.7 mm 0X VA Locking Screw Stardrive 2.7 mm 040 (head 2.4), self-tapping, length mm 0X S 060S VA Locking Screw Stardrive 2.7 mm (head 2.4), self-tapping, length mm, sterile Threaded, rounded head locks securely into the threaded VA-LCP holes to provide angular stability at angles determined by the surgeon. Also securely locks into standard locking holes (LCP) of the plate at the pre-defined angle. Important: For final locking, the 1.2 Nm TLA torque limiting attachment is required. Optional: Variable angle locking screws (VA-LCP) 2.4 mm 0X VA Locking Screw Stardrive 2.4 mm, 140 self-tapping, length 6 40 mm 0X S 160S VA Locking Screw Stardrive 2.4 mm, self-tapping, length mm, sterile All non-sterile screws are also available sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN Synthes 21

24 Screws Cortex screws 2.7 mm X Cortex Screw Stardrive 2.7 mm, 900 self-tapping, length mm X02.962S 969S Cortex Screw Stardrive 2.7 mm, self-tapping, length mm, sterile Cortex screws 2.4 mm X Cortex Screw Stardrive 2.4 mm, 790 self-tapping, length 6 40 mm 0X S 960S Cortex Screw Stardrive 2.4 mm, self-tapping, length mm, sterile For use in round or combi-holes. Optional: Locking head screws 2.4/2.7 mm X Locking Screw Stardrive 2.4 mm, 830 self-tapping, length 6 30 mm X Locking Screw Stardrive 2.7 mm 260 (head LCP 2.4), self-tapping, length 6 60 mm All non-sterile screws are also available sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN 22 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

25 Plates Opening Wedge Plates 2.4/2.7, VA locking Art. No. Length (mm) Spacer (mm) 0X X X X X X All plates are available non-sterile and sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN Synthes 23

26 Instruments Handle with Quick Coupling, length 110 mm Screwdriver Shaft, Stardrive, T8, self-holding Torque Limiter, 1.2 Nm, with AO / ASIF Quick Coupling Handle for Torque Limiters 0.4 / 0.8 / 1.2 Nm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Holding Pin for VA Locking Plates 2.4 / Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

27 Instruments for insertion of 2.7 mm screws Drill Bit 2.7 mm, length 100 / 75 mm, 2-flute, for Quick Coupling Drill Bit 2.0 mm, with marking, length 110 / 85 mm, 2-flute, for Quick Coupling Universal Drill Guide VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm VA-LCP Drill Sleeve 2.7, coaxial, for Drill Bits 2.0 mm Synthes 25

28 Instruments Instruments for insertion of 2.4 mm screws Drill Bit 1.8 mm, with marking, length 110 / 85 mm, 2-flute, for Quick Coupling Drill Bit 2.4 mm, length 100 / 75 mm, 2-flute, for Quick Coupling Universal Drill Guide VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm VA-LCP Drill Sleeve 2.4, coaxial, for Drill Bits 1.8 mm 26 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

29 Instrument for opening wedge plates Opening Wedge Measuring Device Synthes 27

30 Synthes Biomaterials Overview Synthetic and allogenic bone replacement materials have the advantage of uniform quality, unlimited availability and absence of potential complications at a donor site. Additionally, the application of synthetic and allogenic bone graft substitutes reduces the duration of the surgery. Synthes offers a wide range of synthetic biomaterial products in different application forms and with distinct biological properties: chronos chronos Perfusion Concept chronos Inject Osteoconductive, resorbable, synthetic Enhancing chronos with biological factors Injectable remodelling Norian SRS DBX* Injectable stability Osteoinductive power *Facilitated through Synthes Furthermore a comprehensive portfolio of allograft products is available in selected countries. For more detailed information about a specific product or availability of allografts please contact your local Synthes representative. 28 Synthes Variable Angle LCP Opening Wedge Plates 2.4 / 2.7 Technique Guide

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32 01/ Synthes, Inc. or its affiliates Subject to modifications Synthes, LCP and Stardrive are trademarks of Synthes, Inc. or its affiliates Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf All technique guides are available as PDF files at Ö öAA)ä version AA rev. 1

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