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

Model Number	BURR, OVAL, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/03/2025, it was reported by a facilities representative via (b)(4) that an ar-8500obe flute set had experienced breaks when inserting parts into the shaver handpiece.This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed due to the complaint device not being returned for investigation and no photos of the reported failure being provided.The complaint device was not received for investigation.Three packaged and unopened ar-8500obe 8 flute, 5.0 mm x 13 cm oval burrs batch number: 15373446 were received for investigation.Visual evaluation of the three returned devices noted they were the same batch as the complaint devices.No issues were found visually with the unopened devices.Functional testing was performed on one of the three returned devices with a known good ar-8330h and the device was found to be able to attach and disconnect from the shaver handpiece with no issues.No problem found with the returned devices.The most likely cause for the reported failure can be attributed to normal wear and tear of the locking pin in the shaver handpiece used with the device.The most likely cause for the reported failure can also be attributed to misuse due to mishandling/using the complaint device with a worn concomitant device.

• Brand Name: BURR, OVAL, 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: jared engle ; 8009337001
• MDR Report Key: 22308341
• Report Number: 1220246-2025-02623
• Device Sequence Number: 20853569
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: (01)00888867043862(11)250115(17)291231(10)15373446
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 15373446
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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