MAUDE Adverse Event Report: Stryker GmbH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; Screw, fixation, bone

Catalog Number	656316S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "during osteosynthesis of the left distal radius using a variax plate and screws on a displaced fracture, the surgeon encountered difficulties when inserting a 2.7 mm diameter, 16 mm long locking screw.The first four screws were inserted without any problems, but ¿the fifth screw did not lock into the plate's thread and spun freely.¿ furthermore, despite multiple attempts, it was impossible to remove.The surgeon decided to remove the plate and screws and use a new plate and new screws.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that "during osteosynthesis of the left distal radius using a variax plate and screws on a displaced fracture, the surgeon encountered difficulties when inserting a 2.7 mm diameter, 16 mm long locking screw.The first four screws were inserted without any problems, but ¿the fifth screw did not lock into the plate's thread and spun freely.¿ furthermore, despite multiple attempts, it was impossible to remove.The surgeon decided to remove the plate and screws and use a new plate and new screws.
Additional Manufacturer Narrative
Please note the correction to d9.The reported event could not be confirmed since the affected device was not returned.A device inspection was not possible since the affected device was not returned.However, an image was shared by the customer showing a screw inserted in a plate but nothing conclusive can be drawn from this image.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.No indications of material, manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the device affected must be available to determine the exact root cause of the issue.The ifu advises the user that - ¿screws should not be over-tightened during insertion.Excessive over-tightening will compromise the integrity of the screw, screwdriver blade and plate which may result to metal debris generation, stripping of locking threads, breakage or deformation, and lead to loosening.¿ if the device is received or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• 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 ; +1(201)831-5000
• MDR Report Key: 24431118
• Report Number: 0008031020-2026-00241
• Device Sequence Number: 18740047
• Product Code: HWC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2026

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: 656316S
• Device Lot Number: 1000611449
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 07/06/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/11/2026; 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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 Sex: Unknown