MAUDE Adverse Event Report: KEY SURGICAL, LLC; TWIST DRILL BIT

Model Number	SURGICAL DRILL BIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris is not the manufacturer of the twist drill bit subject of the reported event.Steris has notified the manufacturer, gsource of the reported event to internally investigate and evaluate for reportability.As the product distributor, steris is submitting this report solely in response to the received medwatch.The device subject of the reported event is not being returned for evaluation.Udi related data clarification - it should be noted that the lot number referenced in the medwatch report does not match steris distribution records; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility via medwatch report #(b)(4) that the tip of their twist drill bit broke off inside of the patient during a patient procedure.The procedure was completed successfully.No report of injury.

• Brand Name: NA
• Common Device Name: TWIST DRILL BIT
• Manufacturer (Section D): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: coletta cohara ; 8101 wallace road; eden prairie, MN 55344 ; 4404130648
• MDR Report Key: 24405177
• Report Number: 2183785-2026-00001
• Device Sequence Number: 10113913
• Product Code: HTW
• UDI-Device Identifier: 00849771048268
• UDI-Public: (01)00849771048268
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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 Model Number: SURGICAL DRILL BIT
• Device Catalogue Number: KI868415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• 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