Distal Ulnar Locking Plate

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2 INDEX Indications Patient Position Surgical Technique - Step 1 Approach - Step 2 Plate Contouring - Step 3 Fracture Reduction - Step 4 Distal Plate Fixation - Step 5 Confirm Proper Reconstruction - Step 6 Implant Removal 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 Surgical Technique Indications Indications for this implant are fractures of the distal ulna resulting in unstable radioulnar joint, fractures of the ulna head where the articular surface is displaced, rotated, or tilted, and comminuted extraarticular fractures of the ulnar neck. Patient Position The distal ulna should be placed in a supine position holding the forearm in neutral rotation and allowing a direct approach to the distal ulna. STEP 1 APPROACH The access to the ulna is made through a straight longitudinal incision between the tendons of the extensor carpi ulnaris and flexor carpi ulnaris over the distal ulna. STEP 2 PLATE CONTOURING Universal Bending Pliers Contour the plates if necessary with the bending pliers. STEP 3 FRACTURE REDUCTION Reduction Forceps with Points Reduction Forceps, curved As a reference, situate and secure the hooks of the plate on the tip of the ulnar styloid. It might be useful to stabilize the fracture with the help of reduction forceps STEP 4 PLATE FIXATION 4.1 Drill the desired hole Drill Bit, φ1.5, length 110mm Drill Sleeve with Scale, φ1.5 Attach the drill sleeve to the desired hole and predrill through the drill sleeve with the 1.5mm drill bit.

4 4.2 Measure the screw length 4.3 Insert the locking screw STEP 5 CONFIRM PROPER RECONSTRUCTION STEP 6 IMPLANT REMOVAL Depth Gauge for 1.5/2.0 Locking Screws Then remove the drill sleeve and measure the screw length with help of the depth gauge Screwdriver, Stardrive, T6 Insert the appropriate 2.0 locking screw with the screwdriver T6 until seated. Use the image intensifier to check the correct reconstruction of the joint, screw position and length from AP, lateral and multiple oblique views Screwdriver, Stardrive, T6 Unlock all screws from the plate before removing all locking screws from the bone. If locking and cortical screws where used, the last screw to be removed should be a non-locking screw in the shaft to prevent the rotation of the plate while removing the locking screws. 4.4 Final tigthen Optional Handle for Torque Indicating Screwdriver, T6, 0.4Nm Screwdriver Shaft, Stardrive, T6 For final tightening use the Torque Indicating Screwdriver, T6, 0.4Nm Double Drill Guide, φ1.5/φ Countersink for φ2.0 Screws Tap for Cortex Screws φ Screwdriver Shaft, Stardrive, T T-Handle with Quick Coupling The plate offers various options for screw insertion in the distal part permitting to stabilize a wide range of fractures. If length adjustment is needed, one or two 2.0 locking screws should be place into the ulna head in order to securely fix the implant. Place then a 2.0mm cortex screw in the oblong hole to get the correct reduction length. Depending on the bone quality, a combination of cortex and locking screws can be used in the nearby holes to get and optimal fracture stabilization.

5 Distal Ulnar Locking Plate Instruments Drill Bit, φ1.5, length 110mm Drill Sleeve with Scale, φ Countersink for φ2.0 Screws Double Drill Guide, φ1.5/φ Tap for Cortex Screws φ Screwdriver Shaft, Stardrive, T Case, HA Tray for Plate φ Depth Gauge for 1.5/2.0 Locking Screws Handle for Torque Indicating Screwdriver, T6, 0.4Nm Holding Forceps for Plates Holding Forceps for Screws Reduction Forceps with Points Reduction Forceps, curved Case Cover, HA2.0

6 Bending/Cutting Pliers Screwdriver, Stardrive, T Sharp Hook Universal Bending Pliers Handle with Quick Coupling, straight Periosteal Elevator, 3mm T-Handle with Quick Coupling Periosteal Elevator, 5mm Mini Locking Instrument Case Bone Lever, 6.5mm Bone Lever, 8.5mm Bone Lever, 15.5mm

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