MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Catalog Number	656318S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "screws did not lock onto the plate.The procedure was completed using screws of the same part number but from a different lot.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since then device was returned for evaluation and matched the alleged failure.The returned locking screw was visually inspected and found to have uniform nick marks along the thread crests,.The threads located just below the screw head (on the neck region) were significantly deformed, with the crest material crushed and displaced into the adjacent pitch gaps.The next two threads on the neck showed mild nicking and shiny, rubbed surfaces.The pattern of deformation and surface damage indicated that the screw made abrasive contact with the implant during insertion, consistent with misalignment of and the application of excessive tightening force in that position.A functional inspection was conducted in which the returned screw was attempted to be assembled on a sample plate at the proper angle, and it was observed that the screw could be inserted and locked at the proper position.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 labelling did not indicate any abnormalities.No indications if material, manufacturing or design related problems were found during the investigation.Based on the investigation, the most probable root cause is user-related.The deformation observed on the screw- specifically the damage consistent with forces application at a misaligned angle.If more information if provided, the case will be reassessed.
Event or Problem Description
As reported: "screws did not lock onto the plate.The procedure was completed using screws of the same part number but from a different lot.".

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24235224
• Report Number: 0008031020-2026-00107
• Device Sequence Number: 8971093
• Product Code: HWC
• UDI-Device Identifier: 07613327070705
• UDI-Public: (01)07613327070705(17)300806(10)1000608836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180500
• 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): 04/01/2026

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: 656318S
• Device Lot Number: 1000608836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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 Age: 56 YR
• Patient Sex: Female