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	Foreign Body In Patient (2687)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a distal tibia closing wedge osteotomy the drill bit broke off.It was further reported that half of the drill remained inside the patient.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Visual evaluation of the ar-8963-05 shows the tip of the drill bit to be broken off.Functional testing could not be performed due to the damage to the device.Complaint allegation is confirmed.Please see referenced photos attached.The most likely cause for the reported event can be attributed to user error of the device due to prying/leveraging the device during use.

• 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: 20383771
• Report Number: 1220246-2024-08019
• Device Sequence Number: 20842583
• Product Code: HTW
• UDI-Device Identifier: 00888867230651
• UDI-Public: (01)00888867230651(11)211012(10)1392141
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/16/2025

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: 1392141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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