MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number	657316S
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2020
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 implanted.
Event or Problem Description
The surgeon found the screw entwined with metal debris at opening the sterile packaging.The metal debris was removed and the screw was used for procedure.
Event or Problem Description
The surgeon found the screw entwined with metal debris at opening the sterile packaging.The metal debris was removed and the screw was used for procedure.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, neither was the packaging.No other evidence such as pictures were provided as well.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Review of the inspection protocols revealed no deviation from specifications.No indications of manufacturing related problems were found during the investigation.In order to determine the exact root cause of the event, the device/packaging in the original state or other evidence like a picture must be available to trace the causal factor.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10135855
• Report Number: 0008031020-2020-01562
• Device Sequence Number: 3184636
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 12/31/2024
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D61038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1