MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L20MM; SCREW, FIXATION, BONE

Catalog Number	656420S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during treatment for a distal radius fracture, a 2.7 mm cortical screw was inserted to draw the plate and bone surface together, but the screw head sheared off.(the screw head remains stuck in the driver tip.).
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received screw and screwdriver were visually inspected.The inspection revealed that the screw head was completely fractured and detached, with the broken head lodged inside the screwdriver.Additionally, the screw threads exhibited signs of deformation in the crest region of the last two threads.However, it could not be definitively determined whether this deformation occurred during device implantation or explantation.Close examination of the fractured screw head indicated a brittle fracture pattern, consistent with failure caused by the application of excessive torque in the clockwise direction.In the screwdriver torx region, we can also see deformation in the section, which could be from hitting.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.Based on the above investigation, the root cause can be attributed to user related as the device is broken with excessive torque during implantation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During treatment for a distal radius fracture, a 2.7 mm cortical screw was inserted to draw the plate and bone surface together, but the screw head sheared off.(the screw head remains stuck in the driver tip.).

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L20MM
• Common Device Name: SCREW, 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24498480
• Report Number: 0008031020-2026-00359
• Device Sequence Number: 18769253
• Product Code: HWC
• UDI-Device Identifier: 07613327070903
• UDI-Public: (01)07613327070903(17)290320(10)1000553143
• 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): 05/29/2026

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: Lay User/Patient
• Device Catalogue Number: 656420S
• Device Lot Number: 1000553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male