MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM; PLATE, FIXATION, BONE

Catalog Number	657314S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when the locking screw was inserted as usual, metal fragments came out during locking.Just to be sure, the screw was replaced and the problem was resolved".
Additional Manufacturer Narrative
Please note the corrections to d4 lot#, gtin, h6 clinical signs and h6 health impact codes.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: in the received screw, initial thread found worn out indicating improper entry of the screw during insertion.Furthermore, the threads in screw head found unraveled, looks like it got sliced during excess metallic contact either due to misalignment of screw in the plate in terms of angulation or due to excess contact with the sharp point which might have been created during interaction of initial thread of screw with plate.Based on investigation, the root cause was attributed to a user related issue.The event was caused due to misalignment of the screw during insertion leading to abnormal excess contact of the screw with plate and stripping of the threads.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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "when the locking screw was inserted as usual, metal fragments came out during locking.Just to be sure, the screw was replaced and the problem was resolved".

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21439700
• Report Number: 0008031020-2025-00353
• Device Sequence Number: 4336985
• Product Code: HRS
• UDI-Device Identifier: 07613327086850
• UDI-Public: (01)07613327086850(17)290831(10)AK0545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/29/2025

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 Catalogue Number: 657314S
• Device Lot Number: AK0545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown