MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, 2.0MM, CALIBRATED, LONG

Model Number	DRILL BIT, 2.0MM, CALIBRATED, LONG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the drill bit is broken in the foot and ankle rotation box.There was no harm for patient, operator or third party.This was noticed before the surgery.There was no case involvement.No further information received.Update 01-apr-2026 - further information was received: it was reported that during a surgery, the drill bit broke.Per complaint reporter there was no harm for patient, operator or third party.No further information was received from the customer.Update 01-apr-2026 - further information was received: it was reported that the ar-8963-05 has already been used several times.

• Brand Name: DRILL BIT, 2.0MM, CALIBRATED, LONG
• Common Device Name: DRILL BIT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24928326
• Report Number: 1220246-2026-02304
• Device Sequence Number: 21499747
• Product Code: HTW
• UDI-Device Identifier: 00888867230651
• UDI-Public: (01)00888867230651(11)231204(10)1392346
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: DRILL BIT, 2.0MM, CALIBRATED, LONG
• Device Catalogue Number: AR-8963-05
• Device Lot Number: 1392346
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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
• Patient Sex: Unknown