MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/09/2025, it was reported by a sales representative via (b)(4) that an ar-300-b201 burr broke off inside a patient during surgery.The surgeon was able to remove it from the patient after opening up the lateral side of the first metatarsal and pulling out metal piece.This occurred during use in a mis bunion case.
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 most likely cause of the reported failure is user error, including misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation was confirmed based on the customer's attached picture, which shows the device is broken.

• Brand Name: BURR, STRAIGHT, 19.5MM DIAM. 2.0 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: 22664903
• Report Number: 1220246-2025-03140
• Device Sequence Number: 3701913
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: 00888867028654
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 11/05/2025

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, STRAIGHT, 19.5MM DIAM. 2.0 MM
• Device Catalogue Number: AR-300-B201
• Device Lot Number: 082945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown