MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T10 FULL THREAD, 2.7MM/L20MM; SCREW, FIXATION, BONE

Catalog Number	657120S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2025
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: "during the final tightening, the screw head snapped.Broken screw left in patient as would be too traumatic to remove from patient.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during the final tightening, the screw head snapped.Broken screw left in patient as would be too traumatic to remove from patient.".

• Brand Name: BONE SCREW, T10 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 LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21756308
• Report Number: 0008031020-2025-00664
• Device Sequence Number: 21244614
• Product Code: HWC
• UDI-Device Identifier: 07613327071566
• UDI-Public: (01)07613327071566(17)290425(10)1000557084
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 657120S
• Device Lot Number: 1000557084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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