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

Model Number	SYNERGY CW4 ARTHROSCOPY PUMP
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 12/06/2024, a sales representative via (b)(4) reported that an ar-6485 synergy cw4 arthroscopy pump displayed an overpressure error when in use.The unit was connected in a case, and the pressure error code would not let the unit work as intended.The unit would automatically stop while the patient was in the room.The unit was switched to another, and the case was completed successfully without adverse events or harm to the patient.This was discovered during a procedure.
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 wear and tear.

• 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: 21067183
• Report Number: 1220246-2025-09188
• Device Sequence Number: 17017492
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(11)170706(10)21706032
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Report Date (Section B): 07/10/2025

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: 21706032
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown