MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 3.5mm Radiolucent Drill Bit; Instrument, surgical, orthopaedic, ac-powered motor and accessory/attachment

Catalog Number	4200355035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a t2 3×4 procedure, the drill broke while being removed.It was also reported that upon visual inspection, the drill tip was found to be protruding on the opposite side, so an incision and expansion were performed on the opposite side to remove the broken section.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: a follow up report will be sent when the investigation is complete.

• Brand Name: 3.5mm Radiolucent Drill Bit
• Common Device Name: Instrument, surgical, orthopaedic, ac-powered motor and accessory/attachment
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Ireland; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: allison juday ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; +353()214532900
• MDR Report Key: 50775717
• Report Number: 3015967359-2026-00479
• Device Sequence Number: 9472257
• Product Code: HWE
• UDI-Device Identifier: 04546540217165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• 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
• Report Date (Section B): 09/15/2026

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: 4200355035
• Device Lot Number: 26013027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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: Required Intervention
• Patient Sex: Unknown