MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED; BIT, DRILL

Model Number	2.5MM DRILL BIT, CALIBRATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex employee via sems that an ar-8943-42 drill bit broke.This occurred during a case on (b)(6) 2023, with no fragments left in the patient.No additional information was provided.Additional information has been requested.
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.
Event or Problem Description
Additional information was provided where the arthrex subsidiary employee stated this event occurred during a trauma surgery ankle plate 2.7/3.5.The drill did not break.It was just blunt, without wiring, and the drill was used to complete the case.The patient had good bone quality.
Additional Manufacturer Narrative
Additional information: b5.
Additional Manufacturer Narrative
Not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: 2.5MM 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: 16485089
• Report Number: 1220246-2023-06384
• Device Sequence Number: 5899390
• Product Code: HTW
• UDI-Device Identifier: 00888867052499
• UDI-Public: 00888867052499
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/16/2024

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: 2.5MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-42
• Device Lot Number: 022015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: Not provided; 07/23/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 07/18/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown