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	Perforation (2001)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during surgery to place a distal radius plate, the drill bit penetrated toward the dorsal side during drilling, became entangled in the stockinette, and the tip broke off.It broke off outside the patient body, no fragments remain inside the body.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section h6 (health impact code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during surgery to place a distal radius plate, the drill bit penetrated toward the dorsal side during drilling, became entangled in the stockinette, and the tip broke off.It broke off outside the patient body, no fragments remain inside the body.".

• 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: 23969565
• Report Number: 0008031020-2026-00005
• Device Sequence Number: 20790959
• Product Code: LXH
• UDI-Device Identifier: 07613327071870
• UDI-Public: (01)07613327071870(17)351007(10)6000113498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703896S
• Device Lot Number: 6000113498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female