MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-8500fos burr hood is bending into the flutes in the device while doing an acromioplasty.Rpm¿s were 8000 in reverse.Both surgeons stated that they were levering on it moderately, but no different than normal.The rep reported the hood was folding into the flutes, and all pieces of the device remained intact.The issue has occurred six times in the past month.The cases were completed by using new burrs.The rep stated they can only confirm the product lot number for one incident.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.

• Brand Name: BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 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: jared engle ; 8009337001
• MDR Report Key: 19529170
• Report Number: 1220246-2024-05683
• Device Sequence Number: 15379541
• Product Code: GFF
• UDI-Device Identifier: 00888867043831
• UDI-Public: 00888867043831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/13/2024

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,6 FLUT,5.MMX 13CM
• Device Catalogue Number: AR-8500FOS
• Device Lot Number: 11441637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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