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	06/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/5/2023, it was reported by a sales representative via email that an ar-8943-16 drill bit broke during fibular drilling, and the fragments were left inside the patient.This was discovered during an ankle fracture procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the x-ray submitted for evaluation from the field, it is evident that there is a fragment that is visible, aside from the screws.Consequently, arthrex was able to conclude a most likely cause for the reported failure.The most likely cause for the broken screw can be attributed to misuse due to misaligned insertion; or prying/leveraging the screw during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17247211
• Report Number: 1220246-2023-07023
• Device Sequence Number: 20510322
• Product Code: HTW
• UDI-Device Identifier: 00888867052260
• UDI-Public: 00888867052260
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 02/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown