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

Model Number	2.0MM DRILL BIT, CALIBRATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2024
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
On (b)(6)2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8943-16 drill bit broke.This occurred during a simple arthroscopy procedure where a fragment remained in the patient.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.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 of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The complaint is confirmed based on the customer¿s attached pictures, which show an alleged ar-8943-16 drill broken in half.
Event or Problem Description
No revision is required.There was no procedure delay, and no additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was provided on 10/08/2024 where it was stated that this event occurred during the surgical procedure.The device broke as the surgeon began to drill.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8943-16 was received for investigation.Upon visual inspection, the shaft was broken off.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly prying or levering the device during insertion, and extended use in the field.Manufacturing date 2018.Complaint allegation is confirmed.

• Brand Name: 2.0MM DRILL BIT, CALIBRATED
• 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: 20397518
• Report Number: 1220246-2024-08035
• Device Sequence Number: 6517533
• Product Code: HTW
• UDI-Device Identifier: 00888867052260
• UDI-Public: 00888867052260
• 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,Followup
• Report Date (Section B): 09/16/2025

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: 2.0MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-16
• Device Lot Number: 1391803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 12/31/2024; 09/04/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/23/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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