MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, AO, Ø1.7MM

Model Number	DRILL BIT, AO, Ø1.7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/10/2023, it was reported by a sales representative via sems that an ar-18700-58 drill bit broke in half inside the patient's foot.This was discovered during a second metatarsal non-union procedure on (b)(6) 2023.The broken fragment was fully retrieved, and the case was completed successfully.Additional information is 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.
Additional Manufacturer Narrative
Additional information: complaint allegation is 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 of the reported failure is a user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: DRILL BIT, AO, Ø1.7MM
• 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: 17481668
• Report Number: 1220246-2023-07454
• Device Sequence Number: 15239931
• Product Code: HTW
• UDI-Device Identifier: 00888867316294
• UDI-Public: 00888867316294
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/18/2024

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: DRILL BIT, AO, Ø1.7MM
• Device Catalogue Number: AR-18700-58
• Device Lot Number: 1392253
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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