MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L24MM; PLATE, FIXATION, BONE

Model Number	661024S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
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.
Event or Problem Description
It was reported: the drill sleeve seemed to be installed at an angle, and the drill entered at an angle and did not lock.
Event or Problem Description
It was reported: the drill sleeve seemed to be installed at an angle, and the drill entered at an angle and did not lock.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation 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.More information about the event and the device must be available in order to determine the exact root cause of the failure.However, based on the event description stated by the sales representative and the fact that a new screw was successfully implanted thereafter (as per additional information), one of the probable causes of the issue could be attributed to a user related issue.As stated, the surgeon accidently misaligned the drill sleeve which in turn may have misaligned the screw insertion leading to an inadequate locking.During insertion the screw¿s axis must be as perpendicular to the surface of the plate, as possible.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L24MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10242178
• Report Number: 0008031020-2020-01865
• Device Sequence Number: 14122913
• Product Code: HRS
• UDI-Device Identifier: 04546540685841
• UDI-Public: 04546540685841
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• 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): 09/03/2020

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: 06/30/2024
• Device Model Number: 661024S
• Device Catalogue Number: 661024S
• Device Lot Number: D38875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1