MAUDE Adverse Event Report: ARTHREX, INC. 3 X 330MM OVAL BUR RETRACTABLE; BURR,SURGICAL

Model Number	3 X 330MM OVAL BUR RETRACTABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05/07/2025, an arthrex employee reported via email, which was captured in (b)(4), that ar-sov-r30-330, a 3 x 330mm oval bur disposable blade, was used on a shaver in a unilateral laminotomy for bilateral decompression (ulbd).The blade skipped on the cortical bone at the rostral edge of the l5 lamina and created a small durotomy.It was repaired, and the patient is doing fine.The case went smoothly.The case was completed with no further complications.The blade was disposed of and is not available for return.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 3 X 330MM OVAL BUR RETRACTABLE
• 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: 22096015
• Report Number: 1220246-2025-02250
• Device Sequence Number: 20838813
• Product Code: GFF
• UDI-Device Identifier: 00888867503212
• UDI-Public: 00888867503212
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3 X 330MM OVAL BUR RETRACTABLE
• Device Catalogue Number: AR-SOV-R30-330
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown