Femoral Neck System Implant Insertion

Implant Insertion Irrigate and apply suction for removal of debris potentially generated during implant insertion. 1 1. Insert Guide Wire 03.168.001 Angled Guide 130°, for Guide Wires B 3.2 mm tati Guide Wire B 3.2 mm, length 400 mm An tiro 357.399* or 356.830* on Wi re Instruments Central Guide Wire Guide Wire B 3.2 mm, for PFNA Blade Insert a second, unused guide wire as central guide wire, using the 130° angled guide. (1) Use image intensification to place the guide wire slightly inferior to the apex of the femoral head, extending into the subchondral bone on the AP view. (2) In the lateral view, the guide wire should be central in the femoral neck and head. (3)  3  Precautions: • Monitor the position of the wire during insertion and confirm the final position using the image intensifier. Over inserting guide wires could lead to damage to vital organs. • Replace wires if they are bent after insertion. 2  Notes: • The position of the guide wire within the femoral neck and head should be chosen according to the patient’s anatomy before fracture. The implant plate allows a placement of about ±5° compared to the 130° angle. • Depending on the calculated construct size (see page 12), the tip of the bolt will be 5 to 10 mm short compared to the tip of the guide wire. * Available non-sterile and sterile packed. Add “S” to the article number to order sterile products. 9 Implant Insertion 2. Adjust Guide Wire Instruments 357.399* or 356.830* Guide Wire B 3.2 mm, length 400 mm 03.168.002 Correction Guide, for Guide Wires B 3.2 mm (optional) 1. Example: Parallel correction with new entry point anterior. Parallel Wire – new entry point anterior Guide Wire B 3.2 mm, for PFNA Blade If required, use the correction guide and an unused guide wire to adjust the position of the central guide wire in reference to the initial central guide wire. The following three types of adjustments are possible: 1. Parallel Correction (5 mm) Insert the correction guide over the initial wire (orange) and turn the correction guide to define the new entry point (anterior/posterior or inferior/superior). Then use a new wire in the parallel hole (green) and remove the initial wire. 2. Angle Correction (5°) and Entry Point Correction (5 mm) Insert the correction guide over the initial wire (orange) and turn the correction guide to define the new entry point. Then use a new wire in either the left or the right 5°-hole (green). 2. Example: Angle correction towards anterior with new entry point superior. Wire towards anterior – new entry point superior * Available non-sterile and sterile packed. Add “S” to the article number to order sterile products. 11 3. Angle Correction (5°) and Same Entry Point Insert the correction guide over the initial wire (orange hole in side-view), turn the correction guide to choose the new temporary entry point, insert a new wire in the parallel hole (blue) and remove the initial wire. Then use a new wire in either the left or the right 5°-hole (green) to correct the angle. 3. Example: Angle correction towards anterior with same entry point. Initial wire (orange) only shown in sideview). Precautions: • Monitor the position of the wire during insertion and confirm the final position using the image intensifier. Over inserting guide wires could lead to damage to vital organs. • Replace wires if they are bent after insertion. Wire towards anterior – same entry point 11 Implant Insertion 3. Determine Length 1 Instrument 03.168.003 Direct Measuring Device, for Guide Wires B 3.2 mm i on Wi re Slide the direct measuring device over the central guide wire. (1) An tiro tat Read the depth of the guide wire on the direct measuring device. (2) As the guide wire is inserted into the subchondral bone (in the AP view, see page 9), remove 5 mm from the measured depth and choose the next shorter construct size, resulting in the calculated construct size. Example: If you read 102 mm on the direct measuring device, the calculated construct size should be 95 mm (102 – 5 = 97 choose 95 mm). 120 mm 125 mm 130 mm 12 75 75 75 Standard Insertion (Final Construct) m 7 i 15 n. ma 0 m m 5 x. 7 m 3 m Notes: • If patient anatomy demands, a calculated construct size of 70 mm can be achieved by inserting a pre-collapsed 75 mm construct size (3). • Proceed to pages 29 to 34 for pre-collapsed insertion before returning to pages 18 to 25 for locking screw and antirotation-screw insertion. • This technique reduces the tolerated amount of collapse from 20 mm to a minimum of 15 mm and can be performed with other construct sizes as well (see example on page 29). 20 95 mm 100 mm 105 mm 110 mm 115 mm 75 Construct Sizes: 70 mm (see notes below) 75 mm 80 mm 85 mm 90 mm 2 Pre-Collapsed Insertion (Final Construct) 4. Ream for Insertion of Plate and Bolt 1 1 Instrument 03.168.004 Reamer, complete Consisting of: 03.168.005 Drill Bit B 10.2 mm, cannulated, length 251 mm 03.168.006 Reamer B 12.5 mm 03.168.007 Nut, for Reamer Assemble the reamer by sliding the reamer-component over the drill bit until it clicks into place at the calculated construct size (95 mm in the example before). Lock the reamer by adding and fully tightening the nut. (1) 2 3 13 Implant Insertion Ream down until the reamer stops on the bone. (2) 2 An tiro tati on Wi re Notes: • It is recommended that the femoral head is temporarily fixated with an antirotation wire prior to reaming. • An inappropriate position of the antirotation wire may interfere with the proper placement of the implant. • Control guide wire migration, check reaming depth during reaming and ensure complete reaming is achieved using the image intensifier. • When reaming in dense bone, use of continuous irrigation is recommended. • Avoid excessive reaming force during reaming. Remove the reamer. It is important to reinsert the guide wire if it is removed accidentally. To reinsert the wire push the reamer back into the reamed hole (without the use of a power tool) and use the cannulation to reinsert the guide wire into the original position. 14 2 5. Assemble Implant and Insertion Instruments 1 Instruments 03.168.008 Insertion Handle 03.168.009 Insert, for Insertion Handle A A Slide the insert into the insertion handle, without tightening the black screw. (1) Fully insert the bolt with the calculated construct size (95 mm in the example before) into the plate. (2) Option: A longer side plate with two locking holes (2-hole plate) is available as option. 2 B Mount the implant onto the insertion handle. (3) Note: Ensure that the implant is correctly fixed to the insertion instrument and that the bolt is in the completely extended position. C Manually tighten the black screw of the insert to attach the implant. (4) Precaution: Hand-tightening the black screw is sufficient. Using additional tools might cause overtightening. 4 3 C B 15 Implant Insertion 6. Insert Implant 1 Instrument Cylinder, for Insertion Instruments (optional) Wi re 03.168.015 An tiro tati on Insert the implant over the central guide wire into the pre-reamed hole. (1) Precaution: When not using the cylinder, the guide wire will become visible on the outer side of the insert. Ensure not to move the guide wire. (2) Option: The cylinder can be used to manually tap the plate onto the bone. (3) If additional tapping is required, use a standard surgical hammer to slightly tap onto the cylinder. 2 Wi re Use image intensification to confirm the insertion depth and ensure that the plate is inserted down to the bone as well as aligned with the axis of the femoral shaft. (4) 4 tati tiro An 3 An tiro tati on Wi re 4 on Notes: • It is recommended that the femoral head is temporarily fixated with an antirotation wire prior to implant insertion. • Avoid excessive insertion force. • Ensure that the black screw is not turning, if tapping is required during insertion. 16 7. Remove Guide Wire 1 Remove the central guide wire. (1) e Central Guide Wir An tiro tati on Wi re Keep the antirotation wire to prevent loss of reduction and rotation of the head. 17