Olecranon Locking Plate II

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2 INDEX Indications Patient Position Fracture Reduction and Fixation Surgical Technique Step 1 Surgical Approach Step 2 Implantation Step 3 Proximal Locking Screw Insertion Step 4 Distal Screw Insertion Warning This publication describes the recommended procedures for using Double Engine devices and instruments. It offers guidance that you should pay attention to. But as with any such technical guide, the guide alone does not provide sufficient background for direct use of the instrument set, each surgeon should also consider the particular needs of each patient and make appropriate adjustments when required. Instruction by experienced surgeon is still highly recommended. All non-sterile devices must be cleaned and sterilized before use. Multi-component instruments must be disassembled for cleaning. Please follow the instructions provided in our Reprocessing, Care and Maintenance Guide (RCMG-2012). Please refer to Package Insert for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary. Caution The implants are designed for temporary fixation of fractured bone fragments until the bone heals. Therefore, if bone does not heal or bone consolidation is delayed or not sufficient, the system may break. Post-operative care under the guidance of the surgeon is also very important and it must be done to ensure the promotion of bone consolidation.

3 3 4 Surgical Technique Indication Proximal ulnar fractures 6MOBS OFSWF 0MFDSBOPO $IFWSPO 5SJDFQT "ODPOFVT $PNNPO FYUFOTPS UFOEPO 6MOB Patient Position Place the patient either in the lateral or the prone position with the elbow flexed over a slide rest. STEP 1 SURGICAL APPROACH Bone Lever, small Bone Lever, large Make an incision posterior from the supracondylar area to a point 4cm-5cm distal to the fracture. In order to protect the ulnar nerve, make the incision slightly curved to the radial side. STEP 2 IMPLANTATION 2.1 Determine Plate Length and Bend Plate Bending Iron, left Bending Iron, right Select a plate of appropriate length for the fracture. Owing to varying patient anatomy, it might be necessary to contour the plates as needed using bending irons. In order to apply the plate, the triceps tendon may have to be split. Fracture Reduction and Fixation Directly or indirectly reduce the fracture depending on the types of fractures. Assure the coronoid is properly reduced before fixation. Use guide wires for temporary fixation. 2.2 Position Plate Guide Wire, φ1.5, length 150mm Position the plate on the reduced bone, and attach it temporarily with the guide wires. STEP 3 PROXIMAL LOCKING SCREW INSERTION Drill Sleeve for Drill Bits, φ Drill Bit φ2.8, length 200mm Depth Gauge for Locking Screws Torque Indicating Screwdriver, 1.5Nm Screwdriver, hexagonal, φ2.5 1) Thread the 2.8mm drill sleeve into a locking hole until fully seated. Use the 2.8mm drill bit to drill to the desired depth.

4 5 6 2) Remove the drill sleeve and use the depth gauge to determine screw length. 3) Insert the 3.5mm locking screw using the screwdriver. After finish the screw insertion, use torque indicating screwdriver, 1.5Nm to make a final tightening and check that screws are fully inserted by hand. 2) Use the depth gauge to determine the required length of the cortex screw. 3) Use HA3.5mm tap for compact bone. However, there is no need to perform tapping for patient with osteoporotic bone. Note: The audible click on the torque indicating screwdriver will notify the surgeon that the maximum torque value has been reached and that insertion is completed. STEP 4 DISTAL SCREW INSERTION Note: The combi-holes on the plate allow placement of locking screws and cortex screws, thus providing the surgeon with alternative intraoperative options. 4.1 Fixation with 3.5mm Locking Screws If using the threaded portion of the Combi-holes, repeat the steps as described for proximal locking screws insertion. 4.2 Fixation with 3.5mm Cortex Screws Drill Bit, φ2.5, length 112mm Double Drill Guide, φ2.5/φ Depth Gauge for Locking Screws Screwdriver, hexagonal, φ Tap for Cortex Screws φ Holding Sleeve 1) Use the 2.5mm drill bit through the double drill guide to predrill the bone. For the neutral position, press the drill guide down in the nonthreaded hole. In order to achieve compression, place the drill guide at the end of the nonthreaded hole away from the fracture. 4) Insert the 3.5mm cortex screw using small hexagonal screwdriver with holding sleeve. Note: For bone compression at the fracture site, remove the guide wire before inserting cortex screw.

5 7 8 Instruments Guide Wire, φ1.5, length 150mm Screwdriver, hexagonal, φ Drill Bit φ2.8, length 200mm Holding Sleeve Drill Sleeve for Drill Bits, φ Double Drill Guide, φ2.5/φ Depth Gauge for Locking Screws Extraction Screw for Screws, φ Drill Bit, φ2.5, length 112mm Broken Screw Extractor Bending Iron, left T-Handle with Quick Coupling Tap for Cortex Screws φ Screw Forceps, self-holding Torque Indicating Screwdriver, 1.5Nm Drill Sleeve, for Guide Wire φ1.5, short

6 Screwdriver Shaft, hexagonal, φ Holding Sleeve for Torque Indicating Screwdriver Bending Iron, right Instrument Case Reduction Forceps with Points Bone Holding Forceps, self-centering Periosteal Elevator, round edge Periosteal Elevator, straight Bone Lever, small Bone Lever, large