MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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 cuff surgery the tip broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with another device.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 was confirmed.One unpackaged ar-8500rfoe serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that the inner shaft¿s tip was broken off at the weld.Evaluation of the hub found that the material was warped, most likely due to excessive force during use.Functional testing was not performed as the device hub was damaged.The most likely reason for the reported failure is user error, specifically misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• 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: 21114641
• Report Number: 1220246-2025-09321
• Device Sequence Number: 12951997
• Product Code: GFF
• UDI-Device Identifier: 00888867259782
• UDI-Public: (01)00888867259782(11)230303(17)280229(10)15063550
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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,RETR,8 FLUT,5.0MMX13C
• Device Catalogue Number: AR-8500RFOE
• Device Lot Number: 15063550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown