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

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
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 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 Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the distal end of inner tube had broken.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force, misaligned insertion and/or prying/leveraging the device during use.
Event or Problem Description
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.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16086990
• Report Number: 1220246-2023-06021
• Device Sequence Number: 12394329
• 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): 06/06/2024

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: 05/09/2024
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown