MAUDE Adverse Event Report: ARTHREX, INC. BURR ATTACHMENT 2.35 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	BURR ATTACHMENT 2.35 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/21/2025, it was reported by a sales representative via (b)(4) that during an mis: excision, exostosis-left plantar midfoot exostectomy a metal "snapping" sound was heard.Upon inspection, it was found that the non-cutting side of the ar-300-b202 burr that sits within the ar-300b burr attachment had sheared off, leaving a fragment of the burr lodged inside the attachment.This was discovered toward the end of the case with no patient harm.
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.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, such as side-loading, off-axis insertion, or leveraging/prying the device during use.

• Brand Name: BURR ATTACHMENT 2.35 MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 23452090
• Report Number: 1220246-2025-04965
• Device Sequence Number: 9174480
• Product Code: LXH
• UDI-Device Identifier: 00888867099968
• UDI-Public: 00888867099968
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 ATTACHMENT 2.35 MM
• Device Catalogue Number: AR-300B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown