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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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)(6) 2025, it was reported by a facility representative via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump had an issue when setting up the pump at 40 and then it ran constantly and then showed an error code.They switched to a different one to complete the case.No patient was affected.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: complaint allegation is not confirmed.One unpackaged ar-6485synergy cw4 arthroscopy pump was returned for investigation.The returned device was visually inspected, and it was noted signs of humidity on the assembly clear door.The warranty seal was not damaged.The returned device was assembled with tubing and could not be tested.The pump button did not work as required, and it wasn't powered on the console.No problem found.Complaint is not confirmed.
Event or Problem Description
Additional information was received on 04/16/2025: this occurred on (b)(6) 2025, and the procedure name is unknown.There was no delay in the case, nor was additional anesthesia administered.The arthrex tubing used with the pump is unknown.The pump settings at the time of the event were "40." no clamp or pressure test was conducted beforehand.There was a beeped error message, but the display did not mention any alarm message.No photos were taken, and no sales rep was present.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.During evaluation, the ar-6485, synergy cw4 athroscopy pump, showed the same error code.The complaint is confirmed.There was physical damage observed to the pcb control board, the top cover, bezel, the lcd touch screen, and the tubing guide cover.Although the power supply functions, per scar (b)(4) the power supply requires replacement.Confirmed unit software version is current at v1.10 rev 19.Unit is missing qty 3 power cords/cables.The cause is due to a damaged pcb control board.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: 21876739
• Report Number: 1220246-2025-01620
• Device Sequence Number: 7719315
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(10)15030331
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2025

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: 15030331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 09/18/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/07/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown