MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, HL, DIAMONDCUT, 5.0MMX19CM; BURR,SURGICAL

Model Number	BURR, ROUND, HL, DIAMONDCUT, 5.0MMX19CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 23-jan-2026, it was reported by a sales representative via (b)(4) that an ar-6500rbd round burr had metal shards flaking off the distal end of the burr when they were smoothing out some bone.It was visible on the surrounding soft tissue.This was discovered during a procedure with no patient harm.The case was completed with another burr.Additional information provided 02-feb-2026: it was further reported this was discovered during a hip arthroscopy procedure with a minimal delay experienced and no additional anesthesia administered.All fragments were retrieved from the patient.

• Brand Name: BURR, ROUND, HL, DIAMONDCUT, 5.0MMX19CM
• 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: 24315413
• Report Number: 1220246-2026-00535
• Device Sequence Number: 14671374
• Product Code: GFF
• UDI-Device Identifier: 00888867525726
• UDI-Public: (01)00888867525726(11)251125(17)271031(10)15535664
• 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
• Report Date (Section B): 05/18/2026

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, HL, DIAMONDCUT, 5.0MMX19CM
• Device Catalogue Number: AR-6500RBD
• Device Lot Number: 15535664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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