MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/15/2022, it was reported by a sales representative via email that an ar-8500rfoe retractable flushcut burr has broken off in the patient's shoulder.Surgeon was able to remove the broken tip.This was discovered during a procedure.Additional information received on 12/16/2022: this was discovered during a shoulder arthroscopy procedure on (b)(6) 2022.Per sales representative, two ar-8500rfoe retractable flushcut burr broke consecutively during the procedure.All broken fragments from both burr's were retrieved from inside the patient.
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 photo provided by the customer, the complaint allegation is confirmed and, 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 burr during use.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• 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: 19482650
• Report Number: 1220246-2024-05157
• Device Sequence Number: 18136776
• Product Code: GFF
• UDI-Device Identifier: 00888867259782
• UDI-Public: 00888867259782
• 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): 11/15/2024

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: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• Device Catalogue Number: AR-8500RFOE
• Device Lot Number: 15001840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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