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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/21/2024, it was reported by a sales representative via (b)(4) that an ar-8550rfoe retractable flushcut burr had the head of the burr break off into the joint during use.They had to use a grasper to retrieve the broken part of the burr, and a new ar-8550rfoe retractable flushcut burr was opened to finish the case.There was a 5-minute delay in the case to retrieve the broken piece.This was discovered during an arthroscopic rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 5/28/2024: there was not an interruption of flow, but the device broke in the joint and a grasper was used to get this piece out of the shoulder.The patient did not experience any adverse effects and were able to retrieve the broken piece out of the patient.The added 5 minutes to the case.
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: 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 for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• 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: jared engle ; 8009337001
• MDR Report Key: 19549158
• Report Number: 1220246-2024-05888
• Device Sequence Number: 6730383
• Product Code: GFF
• UDI-Device Identifier: 00888867259799
• UDI-Public: 00888867259799
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/30/2025

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: 15212088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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