MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; SCREW, FIXATION, BONE

Model Number	657312S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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 surgeon found the foreign material on this screw at opening of packaging.Instead of this, other one was used for a procedure.The surgeon strongly requested to identify what the foreign material was, like a hair, metal wire, fiber and so on.
Additional Manufacturer Narrative
The reported event could be confirmed only based on the picture sent, the foreign material found was not returned for investigation.The reported screw was used.Furthermore, no pictures of the closed packaging showing the presence of the foreign material was provided.Therefore, more detailed information about the complaint event (such as the foreign material found, the original packaging) must be available in order to determine the root cause of the complaint event.However, the inspection of the screw revealed that the threaded part of the screw is missing some material.Moreover, the screw is heavily damaged (scratches, missing material) - additionally, the foreign material (shown only in the picture sent) seems to be a metallic wire.Therefore, it is probable that while tightening the screw the metallic wire came out.The wire came out most likely because the screw was inserted with too big of an angle, which could have caused the friction between the screw and a sharp part of the plate (the titanium lip for instance), leading to the removal of a part of the material.Hence, 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 investigation report will be updated.
Event or Problem Description
It was reported that the surgeon found the foreign material on this screw at opening of packaging.Instead of this, other one was used for a procedure.The surgeon strongly requested to identify what the foreign material was, like a hair, metal wire, fiber, and so on.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9365359
• Report Number: 0008031020-2019-01872
• Device Sequence Number: 16752123
• Product Code: HWC
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: No Information
• Device Expiration Date: 05/31/2024
• Device Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D33353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1