MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703896S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "a drill bit fractured during orif for a distal radius fracture.A fragment temporarily become lodged in the patient's bone but was promptly removed.The operation was completed without further incident.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was shared for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is received, or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a drill bit fractured during orif for a distal radius fracture.A fragment temporarily become lodged in the patient's bone but was promptly removed.The operation was completed without further incident.".

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23742095
• Report Number: 0008031020-2025-02133
• Device Sequence Number: 15990119
• Product Code: LXH
• UDI-Device Identifier: 07613327071870
• UDI-Public: 07613327071870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/06/2026

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: 703896S
• Device Lot Number: 6000110376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown