MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP; ARTHROSCOPE AND ACCESSORIES

Model Number	SYNERGY CW4 ARTHROSCOPY PUMP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/02/2025, a sales representative reported via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump was producing a pressure fault error code.The issue is believed to be isolated to the pump, as both tube sets are working on different consoles with no error code.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: complaint allegation is not confirmed.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 wear and tear due to repeated use of the device in the field.Manufactured in 2020.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.During evaluation the device functioned.However, physical damage was found to the top cover, the bezel, the tubing guide cover, and the serial label.Confirmed unit software version is v1.10 rev 14.Unit is missing qty 3 power cords/cables see vendor evaluation.

• Brand Name: SYNERGY CW4 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: 22298803
• Report Number: 1220246-2025-02605
• Device Sequence Number: 8628599
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(11)200203(10)22001009
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• 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,Followup
• Report Date (Section B): 10/13/2025

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: SYNERGY CW4 ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6485
• Device Lot Number: 22001009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 06/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 10/06/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown