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

Model Number	2.0MM DRILL BIT, CALIBRATED
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 it was reported by a sales representative via sems that an ar-8943-16 drill bit broke during a fibula orif procedure.The doctor was drilling the far cortex of the fibula with the 2mm drill when the drill broke and became lodged in the fibular inter medullary canal.The drill bit piece was unable to be retrieved.The procedure was completed successfully.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is not confirmed based on the provided photo, as it does not show a broken drill.The picture provided shows the paint and part number information.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 2.0MM DRILL BIT, CALIBRATED
• Common Device Name: BIT, DRILL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16223195
• Report Number: 1220246-2023-06143
• Device Sequence Number: 15104615
• Product Code: HTW
• UDI-Device Identifier: 00888867052260
• UDI-Public: 00888867052260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: 2.0MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-16
• Device Lot Number: 1392234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown