MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT 20 MM, DIA. 3.1 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT 20 MM, DIA. 3.1 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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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
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, STRAIGHT 20 MM, DIA. 3.1 MM
• 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: 23452264
• Report Number: 1220246-2025-04964
• Device Sequence Number: 8961154
• Product Code: LXH
• UDI-Device Identifier: 00888867185821
• UDI-Public: 00888867185821
• 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, STRAIGHT 20 MM, DIA. 3.1 MM
• Device Catalogue Number: AR-300-B202
• 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): 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