MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/06/2025, it was reported by a sales representative via (b)(4) that an ar-8400obe burr began to produce metal shavings were scattered throughout the shoulder while performing a right shoulder arthroscopy with rotator cuff repair.The facility opened a second burr with the same lot number and have the same issue.Solution: opened a burr with a different lot number.This occurred during use in a case.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 devices due to side-loading the devices during use.

• Brand Name: BURR, OVAL, 8 FLUTE 4.0MM X 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: 22095943
• Report Number: 1220246-2025-02245
• Device Sequence Number: 15459358
• Product Code: GFF
• UDI-Device Identifier: 00888867043602
• UDI-Public: 00888867043602
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400OBE
• Device Lot Number: 15396185
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown