MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	AR-8400CBC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: patient was having an ankle arthroscopy.Arthrex 4.0 curved bone cutter, ar8400cbc broke x 2 while using in the patient's ankle.Surgeon states that he got all metal shards out.From operative report: i made several attempts to remove this with arthroscopic shavers, including changing shaver size and using a curved shaver.Actually 2 of the curved shavers actually broke and there was some metallic debris in the area, which was removed arthroscopically.All of the metal debris was removed.I was finally able to find something that would remove the osteochondral defect, which actually turned out to be an angle curette from the bone set.

• Brand Name: ARTHREX®
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 23671341
• Report Number: 23671341
• Device Sequence Number: 15893189
• Product Code: GFA
• UDI-Device Identifier: 00888867043473
• UDI-Public: (01)00888867043473
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025
• Report Date (Section F): 11/14/2025

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: AR-8400CBC
• Device Catalogue Number: AR-8400CBC
• Device Lot Number: 15398581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Date Report Sent to FDA: 11/14/2025