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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/08/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-7300obt oval burr shaver blade bent and broke during the procedure.The blade bent when it was in the medial portion of the trapezius.The technique was carried out correctly.No fragments remained inside the patient.This occurred during use.Additional information requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error of the device due to prying/leveraging the attachment during use.

• 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: 20750811
• Report Number: 1220246-2024-08590
• Device Sequence Number: 11865305
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 07/09/2025
• 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