MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
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
On (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an ar-8550rfoe retractable flushcut¿ burr broke.This occurred during a case where the burrs were switched out to complete the case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely reason for the reported failure is user error, specifically, the application of excessive side loading forces.The complaint allegation was confirmed based on the customer¿s attached picture, which shows the ar-8550rfoe with the inside shaft tip broken off at the weld.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
• Common Device Name: BURR,SURGICAL
• 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: 18259063
• Report Number: 1220246-2023-09145
• Device Sequence Number: 7891020
• Product Code: GFF
• UDI-Device Identifier: 00888867259799
• UDI-Public: 00888867259799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/03/2025

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: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
• Device Catalogue Number: AR-8550RFOE
• Device Lot Number: 15145647
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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