MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	656314S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported, "locking screw did not lock; the screw was idling in the plate.".
Additional Manufacturer Narrative
The reported even could not be confirmed, since the device was not returned, and no other evidences were provided.The event indicates that the screw could not be locked into the plate hole adequately and idled.A non-conformity report (nc) was already initiated based on previous complaints reporting the same event.The nc investigation is not finished yet.A device inspection was not possible since the affected device was not returned, and no other evidences were provided.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "locking screw did not lock; the screw was idling in the plate.".

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10774954
• Report Number: 0008031020-2020-02377
• Device Sequence Number: 14424072
• Product Code: HWC
• UDI-Device Identifier: 07613327070682
• UDI-Public: 07613327070682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 03/09/2025
• Device Model Number: 656314S
• Device Catalogue Number: 656314S
• Device Lot Number: 1000397257
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1