MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, ROUND, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/09/2023, it was reported by a sales representative via sems-06396909 that (2) ar-8500rbe round burrs broke.This occurred during a case where after a couple of minutes of use they could tell something was not working properly.They took the device out of the patient and off of the handpiece and they saw that the bottom plastic had broken off and fell out of the handpiece.They opened the second burr and after about one minute of use, the exact same thing happened.They then opened a third burr with a different lot number and that burr worked properly and was used to complete 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.
Event or Problem Description
Additional information was provided on 11/16/2023 stating this event occurred during a shoulder scope, the subacromial decompression to be exact on (b)(6) 2023.All of the fragments were retrieved.
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
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 reason for the reported failure is an internal manufacturing issue.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: BURR, ROUND, 8 FLUTE 5.0MM X 13CM
• 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: 18273529
• Report Number: 1220246-2023-09206
• Device Sequence Number: 14956082
• Product Code: GFF
• UDI-Device Identifier: 00888867043879
• UDI-Public: 00888867043879
• 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,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: BURR, ROUND, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500RBE
• Device Lot Number: 15045288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided; 02/18/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 11/22/2024; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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