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INDEX Indications Preoperative Planning Patient Position Surgical Technique - Step 1 Open Humerus - Step 2 Calibrate The Nail - Step 3 Insert Nail - Step 4 Proximal Locking - Step 5 Assemble Calibrating Pin - Step 6 Distal Locking 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. - Step 7 Insert End Cap - Step 8 Implant Removal 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 4 Surgical Technique Indications -Proximal Humeral Fractures -Humeral Shaft Fractures Preoperative Planning Estimate the nail diameter and length using the radiographic ruler for the humeral nail. To estimate nail diameter, place the radiographic ruler on the AP or lateral X-ray of the uninjured humerus and measure the diameter of the medullary canal at the narrowest part that will contain the nail. To estimate nail length, place the radiographic ruler on the AP X-ray of the uninjured humerus and select the appropriate nail length base on patient anatomy. When selecting nail size, consider canal diameter, fracture pattern, patient anatomy and postoperative protocol. Patient Position Place the patient supine on an extension table or a radiolucent operating table. Abduct the affected arm and place it on the support pad under image intensification. Or lay the patient with beach-chair position. STEP 1 OPEN HUMERUS 1.3 Open medullary canal. 1.1 Approach 110301800 Reverse Awl Make a 3~4mm longitudinal incision, slightly anterior lateral acromion Open and drill into the medullary canal using the reverse awl. to cleave the deltoid. Note: To protect the axillary nerve, cleave the deltoid with less than Note: The axis of the reverse awl shape a 7 angle with sagittal plane and overlap with the coronal plane. 5cm to the distal acromion. 1.2 Determine entry point The entry point is in the medial tip of humeral tuberculum majus, approximate 5mm of sulcus tendon in the posterior musculus biceps brachii. 7 Note: Ensure that the entry point is accurate so as to protect the axillary nerve. L2 L L1 1.4 Reduction 110303300 Guide Wire, φ2.0, length 660mm, with olive head Insert the guide wire into the medullary canal after open or closed reduction. Note: Ensure that the guide wire is in the right position of the medullary canal under image intensification. 1.5 Determine nail length Measure the length of L2, the length of the exposed guide wire. Subtract L2 from the overall length of the guide wire (L1), and the appropriate nail length L= L1- L2. Note: Reconfirm the preoperative measured nail length.
5 6 1.6 Ream STEP 2 CALIBRATE THE NAIL STEP 4 PROXIMAL LOCKING 4.2 Drill 110547100 Flexible Reamer, φ6.5 110547200 Flexible Reamer, φ7.0 110547300 Flexible Reamer, φ7.3 110547400 Flexible Reamer, φ8.3 Gradually enlarge the canal with the flexible reamer along the guide wire up to the desired diameter, starting from the smallest size. Ream to a diameter of 0.5mm greater than the nail diameter. Do not move the guide wire when removing the flexible reamer. Select a nail with appropriate length and diameter. Connect the nail to the insertion handle. Wholly assembled to calibrate the nail Note: The nail needs to be calibrated preoperatively. 4.1 Install the proximal oblique aiming device. 110342000 Proximal Aiming Device, oblique 110342100 Locking Screw for Aiming Arm 110340500 Protection Sleeve, φ10.0, length 85mm 110340700 Trocar, φ8.0 Install the proximal aiming device onto the insertion handle with the locking screw. Insert the protection sleeve and trocar. Make an incision on the skin and cleave the soft tissue to bone surface. Insert the protection sleeve and trocar to bone surface. 110340900 Inner Sleeve, φ8.0 110340300 Drill Bit, φ3.2, length 200mm 110341200 Fixation Sleeve for Drill Bits Remove the trocar and insert the inner sleeve, then drill hole with the 3.2mm drill bit through the inner sleeve. Note: Pre-estimate the depth and install the fixation sleeve at the appropriate mark tick before drilling or drill under image intensification. STEP 3 INSERT NAIL 3.2 Insert nail 4.3 Measure the length of locking screw 4.4 Insert locking screw 3.1 Assemble the nail 110303400 Guide Wire, φ2.0, length 660mm, without olive head 110342400 Depth Gauge 110341100 Screwdriver, hexagonal, φ3.0 110341700 Insertion Handle for Humeral Nail 110342200 Connecting Shaft for Aiming Arm 110310800 Ratchet Wrench Attach the nail to the insertion handle, then connect the nail with the connecting shaft, tighten the nail by the ratchet wrench. Remove the guide wire with olive head, and insert guide wire without olive head. Insert the nail along the guide wire. Slightly rotate the insertion handle to facilitate the nail insertion. If there is great resistance, ream or select a nail of smaller size. Ensure that the canal is at least 1mm wider than the nail diameter. Note: Ensure that the nail is advanced into 5mm below the proximal humeral bone surface. Remove the drill bit and inner sleeve. Read off the length of required locking screw using the depth gauge. Note: Ensure that the protection sleeve is tightly pressed on the bone cortex during measuring. Insert 5.0mm locking screw of appropriate length using hexagonal screwdriver through the outer protection sleeve until it meets the 0 scale on the screwdriver. Optional instrument 110341400 Inserter-Extractor for Humeral Nail Attach the inserter-extractor on the connecting shaft and use light hammer blows on the connector to insert the nail.
7 STEP 5 STEP 6 4.5 Insert other locking screws ASSEMBLE CALIBRATIONG PIN 5.4 Fix the calibrating pin DISTAL LOCKING 110340400 110340600 110340800 110340200 110341200 5.1 Install aiming arms 110342800 110342900 6.1 Drill 110341800 110342100 110341900 110343300 110343100 110343200 Remove the drill bit and drill sleeve, then insert the calibrating pin. Ensure that the calibrating pin is in contact with the nail plateau. Connect the calibrating pin and the straight aiming arm using the U-clip. Protection Sleeve, φ8.0, length 85mm Trocar, φ6.0 Inner Sleeve, φ6.0 Drill Bit, φ3.0, length 200mm Fixation Sleeve for Drill Bits Repeat the same operation as described above to insert the other two locking screws. Remove the oblique aiming device and insert a 3.6mm locking screw like the above operation. Verify locking screw length under image intensification to ensure a correct position. 5.2 Drill 110343000 110340200 110341200 Drill Sleeve Drill Bit, φ3.0, length 200mm Fixation Sleeve for Drill Bits Remove the trocar, and insert the drill sleeve. Insert the φ3.0mm drill bit along the drill sleeve and penetrate through the single bone cortex Aiming Arm, straight Locking Screw for Aiming Arm Distal Aiming Device, curved Locking Screw for Aiming Arm II Protection Sleeve, for Calibrating Pin Trocar, φ6.0, length 96mm Calibrating Pin U-Clip 8 110340400 110340600 110340800 110340200 110341200 Protection Sleeve, φ8.0, length 85mm Trocar, φ6.0 Inner Sleeve, φ6.0 Drill Bit, φ3.0, length 200mm Fixation Sleeve for Drill Bits Note: The accurate implantation of locking screws is determined by the direct contact of calibrating pin and the nail plateau Install the protection sleeve and trocar at the curved aiming arm. Make an incision in the fixed position of the bone cortex and cleave the soft tissue to bone surface. Then insert the protection sleeve and trocar to bone surface. Remove the trocar and insert the inner sleeve. Drill through the inner sleeve using 3.0mm drill bit. 5.3 Clear debris 6.2 Measure the length of locking screw 6.3 Insert locking screw 110343400 110342400 110341100 Connect the straight aiming arm with the insertion handle by tightening the locking screw for aiming arm. Along the calibration hole, insert the protection sleeve and trocar to the bone cortex. Drill Bit with Flat Head Remove the drill bit, and then insert a φ3.2mm drill bit with flat head to clear the bone debris on the operation plateau. Depth Gauge Drill through both cortices until the tip of the drill bit just breaks through the medial cortex. Remove the drill bit and inner sleeve. The required length of the locking screw can be determined directly by measuring with the depth gauge for locking screw. Screwdriver, hexagonal, φ3.0 Insert an appropriate 3.6mm locking screw using hexagonal screwdriver through outer sleeve until it meets the 0 scale on the screwdriver.
9 10 Instruments 110810000 110301800 Reverse Awl 110340200 Drill Bit, φ3.0, length 200mm 6.4 Repeat steps 6.1-6.3 to insert the other 3.6mm locking screw. Note: Protect the brachial artery and radial nerve when inserting the distal locking screw. It will be more stable to place two locking screws. Just insert one if it is difficult to insert two locking screws. STEP 7 INSERT END CAP 110341000 Screwdriver Shaft, hexagonal, φ3.0 110341100 Screwdriver, hexagonal, φ3.0 The end cap protects the inner thread of the nail from tissue ingrowth and facilitates subsequent implant removal. Remove the proximal aiming arm and insertion handle. Hold the end cap with the screwdriver shaft and slightly screw it into the nail end. Tighten the end cap using the screwdriver. Ensure the nail and end cap are fully countersunk in the humeral head, so that shoulder function remains unhindered, including during abduction. For this reason, an end cap without extension should be used where possible. 110340300 Drill Bit, φ3.2, length 200mm 110340400 Protection Sleeve, φ8.0, length 85mm 110340500 Protection Sleeve, φ10.0, length 85mm 110340600 Trocar, φ6.0 STEP 8 IMPLANT REMOVAL 110341100 Screwdriver, hexagonal, φ3.0 110341400 Inserter-Extractor for Humeral Nail 110341500 Universal Joint 110310800 Ratchet Wrench Remove locking screws and end cap successively with hexagonal screwdriver. Mount the universal joint and nail using ratchet wrench, and connect the universal joint to the inserter-extractor. Ensure every component is completely tightened. Perform the slide hammer to remove the nail. 110340700 Trocar, φ8.0 110340800 Inner Sleeve, φ6.0
11 12 110340900 Inner Sleeve, φ8.0 110341700 Insertion Handle for Humeral Nail 110341000 Screwdriver Shaft, hexagonal, φ3.0 110341800 Aiming Arm, straight 110341100 Screwdriver, hexagonal, φ3.0 110341900 Distal Aiming Device, curved 110341200 Fixation Sleeve for Drill Bits 110301700 L-Wrench, hexagonal, φ3.0 110342000 Proximal Aiming Device, oblique 110341400 Inserter-Extractor for Humeral Nail 110342100 Locking Screw for Aiming Arm 110341500 Universal Joint 110342200 Connecting Shaft for Aiming Arm 110341600 Radiographic Ruler for Humeral Nail 110310800 Ratchet Wrench
13 110342400 Depth Gauge 110343300 Locking Screw for Aiming Arm ＩＩ 110303300 Guide Wire, φ2.0, length 660mm, with olive head 110343400 Drill Bit with Flat Head 110303400 Guide Wire, φ2.0, length 660mm, without olive head 110547100 Flexible Reamer, φ6.5 110342800 Calibrating Pin 110547200 Flexible Reamer, φ7.0 110342900 U-Clip 110547300 Flexible Reamer, φ7.3 110343000 Drill Sleeve 110111400 Flexible Reamer, φ8.3 110343100 Protection Sleeve, for Calibrating Pin 110343200 Trocar, φ6.0, length 96mm 14
15 16 110810001 Instrument Case