MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER, CURVED; SAW BLADE

Model Number	BONE CUTTER, CURVED
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/28/2025, an fda medsun notification was received via email.A facility representative reported that two ar-8400cbc bone cutters broke during use on a patient¿s ankle, resulting in metallic debris within the surgical site.According to the operative report, all metallic debris was retrieved arthroscopically.The surgeon noted that both devices malfunctioned and failed to function as intended.The procedure was completed using an angled curette from the bone set.This incident occurred during a left ankle arthroscopy with debridement and microfracture of a medial talus osteochondral defect procedure in (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 30-jan-2026: during a procedure on (b)(6) 2025, two ar-8400cbc bone cutters reportedly broke while cutting.The surgery was not delayed, no additional anesthesia was required, and no adverse effects were reported.No additional surgical intervention was needed.
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 returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in damage to the device.Directions for use dfu-0215-eo revision 1 - disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection, and shaverdrill devices.F.Precautions: 7.Excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases, will cause irreversible damage to the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: BONE CUTTER, CURVED
• Common Device Name: SAW BLADE
• 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: 23837740
• Report Number: 1220246-2025-05681
• Device Sequence Number: 14710446
• Product Code: GFA
• UDI-Device Identifier: 00888867043473
• UDI-Public: (01)00888867043473(11)250303(17)300228(10)15398581
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: BONE CUTTER, CURVED
• Device Catalogue Number: AR-8400CBC
• Device Lot Number: 15398581
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 04/02/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/13/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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