MAUDE Adverse Event Report: Stryker GmbH Drill Bit, AO MIS T15; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Catalog Number	542110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgeon was drilling using 542110 through the targeter.The drill bit broke inside of the tibial canal attempting to drill through the far cortex.The tip of the drill bit that broke off stayed inside the tibia.The surgeon decided it would cause more harm than good to try and fish the broken piece out of the tibia.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: Drill Bit, AO MIS T15
• Common Device Name: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
• 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 ; +1(201)831-5000
• MDR Report Key: 50061368
• Report Number: 0008031020-2026-00919
• Device Sequence Number: 9349840
• Product Code: HWE
• UDI-Device Identifier: 07613327625042
• UDI-Public: 07613327625042
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 542110
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown