MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE AND ACCESSORIES

Model Number	CWIII ARTHROSCOPY PUMP
Medical Device Problem Codes	Increase in Pressure (1491); Pressure Problem (3012)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/18/2025
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 02/19/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 main pump tubing experienced an overpressure event.This was discovered during use in a knee surgery case.The pump used in the surgery was an ar-6475 continuous wave iii.During surgery, the amount of water increased abnormally.The patient's knee became swollen, and the patient was unable to bend his leg.Finally, the surgery was called off.Additional surgery is being considered at a later date.Additional information requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: CWIII ARTHROSCOPY PUMP
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 21558095
• Report Number: 1220246-2025-00852
• Device Sequence Number: 9601964
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K024291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown