MAUDE Adverse Event Report: ARTHREX, INC. ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM; BURR,SURGICAL

Model Number	ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 11/21/2025, a facility representative reported via (b)(4) that the surgeon had issues with the ar-6500rbe 8-flute 5.0mm x 19cm round burr shedding metal fragment debris in both forward and reverse at 8000 rpm during a cam resection while performing a hip arthroscopy.The size of the fragments was tiny, like specks.No patient was affected.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to use-related factors, specifically excessive side-loading during use.This determination is consistent with the precautions described in dfu-0215-eo, revision 1 ¿ disposable arthroscopic shaver blades, burrs, powerpick¿, powerasp¿, nanoresection¿, and shaverdrill¿ devices, which state: f.Precautions (6) do not allow the rotating portion of any device to contact metallic objects (e.G., cannulas, arthroscopes).Such contact may cause damage ranging from edge dulling to fracture of the tip.If contact occurs, inspect the device and replace it if cracks, fractures, or dulling are observed.(7) excessive side-loading during use does not improve cutting performance and may cause irreversible damage to the device.(8) excessive loading on the powerasp device may disengage the cam mechanism and stall cutting effectiveness.

• Brand Name: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• 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: 23759380
• Report Number: 1220246-2025-05527
• Device Sequence Number: 21375010
• Product Code: GFF
• UDI-Device Identifier: 00888867039452
• UDI-Public: (01)00888867039452(11)250724(17)300630(10)15471892
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• Device Catalogue Number: AR-6500RBE
• Device Lot Number: 15471892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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