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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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 (b)(4) 2025, a sales representative via phone that (2) ar-300-b201 burrs broke.This occurred during a cheilectomy procedure on (b)(6) 2025 while shaving the first burr snapped, the fragment was removed and the second one was attempted which also broke.The fragments were retrieved and the case proceeded using an ar-300-b202.This resulted in a 12-15 minute delay in which it is unsure if additional anesthesia was administered.There was no harm on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the device was broken.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• 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: 22554773
• Report Number: 1220246-2025-02978
• Device Sequence Number: 15847056
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: (01)00888867028654(11)250201(17)300131(10)085048
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/17/2025

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: 085048
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown