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

Model Number	BURR, ROUND, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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's employee via an email that for 1 unit of ar-8400rbe, round burr, 8 flute, 4.0 mm x 13 cm, and 1 unit of ar-8500rbe, round burr, 8 flute, 5.0 mm x 13 cm, the spherical grinding head were shedding a large amount of chips.Both ar-8400rbe and ar-8500rbe encountered the same issue.This was detected during an ankle arthroscopy surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-8400rbe and ar-8500rbe.There were no patient harm and no secondary surgery needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8400rbe, round burr, 8 flute, 4.0 mm x 13 cm, batch number 15300568, was received for investigation.Visual inspection noted significant surface damage to the inner attachment as well as the outer tube.The most likely cause for the reported failure can be attributed to user error, due to insufficient fluid flow during use and/or prying/leveraging the attachment during use.Directions for use (dfu) disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection and shaverdrill devices: e.Warnings.5.Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure.F.Precautions.7.Excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases will cause irreversible damage to the device.9.Irreversible damage to all devices will result if they are run without the flow of irrigation.Complaint allegation is confirmed.

• Brand Name: BURR, ROUND, 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: 23086226
• Report Number: 1220246-2025-03927
• Device Sequence Number: 13187252
• Product Code: GFF
• UDI-Device Identifier: 00888867043626
• UDI-Public: (01)00888867043626(11)240812(17)290731(10)15300568
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/17/2025

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, ROUND, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400RBE
• Device Lot Number: 15300568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown