MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,8 FLUT,5.0MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,8 FLUT,5.0MMX 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/04/2024, it was reported by a sales representative via (b)(4) that a ar-8500foe burr, flushcut oval, had the sleeve of the burr bent.The case was completed successfully with no impact on the patient.This was discovered during a procedure, with no patient harm.
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 due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: BUR,OVAL,FLUSHCUT,8 FLUT,5.0MMX 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: 20736267
• Report Number: 1220246-2024-08581
• Device Sequence Number: 8287911
• Product Code: GFF
• UDI-Device Identifier: 00888867043824
• UDI-Public: (01)00888867043824(11)240710(17)290630(10)15285537
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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,8 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500FOE
• Device Lot Number: 15285537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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