MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10, 3.5X14MM; PLATE, FIXATION, BONE

Catalog Number	40-35614S
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
During variax fibula surgery, the locking screw did not lock in the most distal hole.The screw was once removed, removal and cleaning of soft tissue was performed, but the issue was not resolved.The surgeon exchanged the screw with another same size screw, but the screw could not be locked.Therefore, re-drilling was performed using drill sleeve but the issue was not resolved.Ultimately, the surgery was finished with the screw unlocked and lag screw fixation was added using 3.5mm non-locking screw in order to increase fracture stability.
Additional Manufacturer Narrative
The reported event that locking screw, t10, 3.5x14mm was alleged of issue (no locking effect) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the affected device must be available in order to determine the root cause of the complaint event.A review of the labeling did not indicate any abnormalities.The instructions for use states that ¿responsibility for proper selection of patients, adequate training of the surgeon, the choice and placement of implants, post-operative treatment, and the decision to leave or remove implants postoperatively, rests with the surgeon.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.Product not returned.
Event or Problem Description
During variax fibula surgery, the locking screw did not lock in the most distal hole.The screw was once removed, removal and cleaning of soft tissue was performed, but the issue was not resolved.The surgeon exchanged the screw with another same size screw, but the screw could not be locked.Therefore, re-drilling was performed using drill sleeve but the issue was not resolved.Ultimately, the surgery was finished with the screw unlocked and lag screw fixation was added using 3.5mm non-locking screw in order to increase fracture stability.

• Brand Name: LOCKING SCREW, T10, 3.5X14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7567112
• Report Number: 0008031020-2018-00415
• Device Sequence Number: 1277840
• Product Code: HRS
• UDI-Device Identifier: 04546540539410
• UDI-Public: 04546540539410
• Combination Product (Y/N): N
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: 40-35614S
• Device Lot Number: 1000286379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other