MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM; BURR,SURGICAL

Model Number	BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
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
On 02/28/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-7300bt burr 3.0 bone blade broke.This occurred during use and they had to open another one to finish the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
Additional information was provided on 03/11/2025 where it was reported that this event occurred during a wrist arthroscopy procedure in the middle of the procedure.Another blade was used to complete the case.The patient had a good bone quality.All fragments were able to be retrieved from the patient.There was no delay or additional anesthesia administered.There was no harm to the patient.

• Brand Name: BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
• 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: 21619478
• Report Number: 1220246-2025-00978
• Device Sequence Number: 15130003
• Product Code: GFF
• UDI-Device Identifier: 00888867041950
• UDI-Public: (01)00888867041950(11)240410(17)290331(10)15232786
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 09/24/2025

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,SJ,10 FLUT,3.0MMX 7CM
• Device Catalogue Number: AR-7300OBT
• Device Lot Number: 15232786
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 03/11/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 08/04/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• 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