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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
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
It was reported that during an hip arthroscopic surgery plastic debris was produced.The plastic was visible in the camera and could be removed in time.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure is user error.This may include excessive force, misaligned insertion, and/or the connector hub not being correctly connected to the handpiece.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22742506
• Report Number: 1220246-2025-03328
• Device Sequence Number: 15580092
• Product Code: GFF
• UDI-Device Identifier: 00888867039452
• UDI-Public: (01)00888867039452(11)250120(17)291231(10)15375428
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 15375428
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown