MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
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
It was reported that during an arthroscopic shoulder surgery the burr tip geometry broke off.All parts were retrieved from the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-8500fot, burr device, batch 15185057, was received for investigation.Visual evaluation: under a magnifier, deep striation marks along the outer tub were noted.The hood had nicks around it, and the cutting tip was damaged along the blades.Remnants of contaminant material were caught along the shaft window.Material degradation was evident throughout the device.Functional testing was not performed due to the damage to the device.The most probable cause is by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.

• Brand Name: BUR,OVAL,FLUSHCUT,12 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: 20043805
• Report Number: 1220246-2024-07238
• Device Sequence Number: 18136977
• Product Code: GFF
• UDI-Device Identifier: 00888867043848
• UDI-Public: 00888867043848
• 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): 03/10/2025

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,12 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500FOT
• Device Lot Number: 15185057
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2023
• 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