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

Catalog Number 40-35614S

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event 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.

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7567112
• MDR Text Key: 110173725
• Report Number: 0008031020-2018-00415
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540539410
• UDI-Public: 04546540539410
• Combination Product (y/n): N
• PMA/PMN Number: K063875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: 40-35614S
• Device Lot Number: 1000286379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other