MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 10 FLUTE, 3.5MM; BURR,SURGICAL

Model Number	BURR, ROUND, 10 FLUTE, 3.5MM
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 (b)(6) 2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-9350rbt burr had a blockage in the inner tube.After removing and cleaning the parts and reassembling, a rubber tube came out, making it unusable.The rubber tube was removed, and the device became usable, but the connection was poor, and it could not be used normally, so it was discontinued.No residue remained inside the body, and no health problems have been reported.A new unit of the same model number was opened and the operation continued, which was completed without incident.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-visual inspection identified that the shrink tubing on the inner tube was wrinkled and damage.-the functional evaluation was not performed due to the damage to the shrink tubing.Per dfu-0215-eo - f - precautions - 12.If disassembly of straight devices is required to remove a clog, care must be taken to prevent damage to the teflon tubing on the inner tube during re-assembly.The most likely cause of the reported failure is user error in removing the inner tube from the outer tube, which damaged the shrink tubing of the device.

• Brand Name: BURR, ROUND, 10 FLUTE, 3.5MM
• 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: 23961170
• Report Number: 1220246-2026-00069
• Device Sequence Number: 18544466
• Product Code: GFF
• UDI-Device Identifier: 00888867215702
• UDI-Public: (01)00888867215702(11)250509(17)300430(10)15434026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/28/2026

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, ROUND, 10 FLUTE, 3.5MM
• Device Catalogue Number: AR-9350RBT
• Device Lot Number: 15434026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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