MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, ROUND, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 16th april 2025, it was reported by an arthrex employee via email that for 8 units of ar-8500rbe, round burr, 8 flute, 5.0 mm x 13 cm, the internal drive mechanism totally shredded rendering it unusable.(customer reported 8 burrs suffered from the same issue (6 pictured).This was detected during use in a hip arthroscopy on (b)(6) 2025.The procedure was completed successfully with 8 burrs used on 1 patient.On (b)(6) 2025: the customer stated that they kept using the burrs until they wore out (that was how it was presented to the arthrex employee).
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The failure is most likely attributed to user error due to excessive force on the tip of the device, which causes the inner tube to stall while the motor continues to spin and shear off the hub.Refer to the precaution listed in dfu-0215-eo: 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 complaint allegation was confirmed based on the customer's attached picture, which shows the hub connector damaged with the blue plastic material shredded.

• Brand Name: BURR, ROUND, 8 FLUTE 5.0MM 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: 21908303
• Report Number: 1220246-2025-01730
• Device Sequence Number: 4221294
• Product Code: GFF
• UDI-Device Identifier: 00888867043879
• UDI-Public: (01)00888867043879(11)220322(17)270228(10)14942064
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 5.0MM X 13CM
• Device Catalogue Number: AR-8500RBE
• Device Lot Number: 14942064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown