MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,8 FLUT,5.0MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,8 FLUT,5.0MMX 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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 a shoulder surgery the burr broke when shaving of the acromion.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-8500foe burr, oval, flushcut¿, 8 flute, 5.0 mm x 13 cm serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to device damage.Visual inspection revealed that the outer tube hood was bent, indicating excessive side loading force was applied.The most likely cause(s) of the observed and reported failure are user error, misaligned insertion, or excessive force to leverage/pry the device.

• Brand Name: BUR,OVAL,FLUSHCUT,8 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: 20226786
• Report Number: 1220246-2024-07656
• Device Sequence Number: 14301195
• Product Code: GFF
• UDI-Device Identifier: 00888867043824
• UDI-Public: 00888867043824
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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,8 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500FOE
• Device Lot Number: 15290994
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2024
• 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