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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
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 30th december 2025, it was reported by an arthrex employee via email that for 2 units of ar-8400rbe, round burr, 8 flute, 4.0 mm x 13 cm, the spherical grinding head were shedding a large amount of chips.This was detected during use in an ankle joint repair surgery on (b)(6) 2025.The procedure was completed successfully as another brand's product was used.There was no patient harm and no secondary procedure needed.No dualwave outflow tubing used in the case, there was an uninterrupted flow of irrigation through the device during its use.Shaver consoles and handpieces type and serial number is (b)(6).
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection noted chipping at the edges of the inner tube tip.Chipping was also observed along the edges of the slots and at the tip of the outer tube.Per dfu-0215-eo- f precautions 6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.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.The most likely cause is attributed to misuse of the device, including exposure to excessive mechanical forces, misaligned insertion, side loading during use and/or allowing the rotating portion to touch any metallic object during use.

• 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: 24067557
• Report Number: 1220246-2026-00202
• Device Sequence Number: 10282766
• 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): 04/30/2026

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, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400RBE
• Device Lot Number: 15300568
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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