MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number	PLSL3516
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the cortical screw stripped while being inserted into a right mtp fusion plate.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the mishandling of the device.The returned device presents significant damage to the screw-head due to high deformation, missing material - which could have led to an inability to screw with the plate.Screw-head interface at which screwdriver comes in contact is heavily damaged, representing the application of excessive mechanical force while tightening.Therefore, this case is classified as a user related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the cortical screw stripped while being inserted into a right mtp fusion plate.

• Brand Name: LOCKING SCREW ANCHORAGE 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10285664
• Report Number: 0008031020-2020-01917
• Device Sequence Number: 485489
• Product Code: HRS
• UDI-Device Identifier: 07613252262350
• UDI-Public: 07613252262350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083447
• 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): 10/14/2020

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 Model Number: PLSL3516
• Device Catalogue Number: PLSL3516
• Device Lot Number: Y18930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1