MAUDE Adverse Event Report: ARTHREX, INC. ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM; BURR,SURGICAL

Model Number	ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 12/06/2024, it was reported by a sales representative via (b)(4) that (qty.(b)(4) of an ar-6500rbe round burr, hl, 8 flute, 5.0 mm x 19 cm had the burr break during a case and fell where the shaver handle connects.Nothing fell inside the patient.This was discovered during a procedure, with no reported patient harm.Additional information was received on 12/12/2024: it was confirmed that only a (qty.(b)(4) of an ar-6500rbe round burr broke during a hip arthroscopy procedure on (b)(6) 2024.No debris was produced while the devices were in use.The case was completed successfully, and no further information was provided.There was no case delay.No adverse effects on the patient were reported.
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: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• 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: 21057619
• Report Number: 1220246-2025-09169
• Device Sequence Number: 7948205
• Product Code: GFF
• UDI-Device Identifier: 00888867039452
• UDI-Public: (01)00888867039452(11)240814(17)290731(10)15302169
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• Device Catalogue Number: AR-6500RBE
• Device Lot Number: 15302169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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