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	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/20/2024, it was reported by a facility representative via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump was over pressure rising in joint.No reported patient harm.No further information provided.This was discovered during a procedure.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-6485 synergy cw4 arthroscopy pump serial number (b)(6), was received for evaluation.Upon visual inspection, found regular signs of wear with some marks on the top and side of the housing.The returned device was assembled with ar-6411 lot# 65043383, and ar-6421 lot# 65708975 pump tubing and tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was connected to the power and turned on.After selecting the desired pressure, the run button was pressed to start the machine.The pump ran for 52 minutes with no issues.No changes in the pressure were noted during the time the machine was tested.Pressure fault test: when the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected¿no problem found.A clamping test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an overpressure failure on the pump and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate that the pump triggered an alarm, and the rollers did stop moving.Pressure testing evaluation with the pressure calibrator set at 100 and 200 mmhg gave the pump pressure results of 46 and 91, respectively.These results indicated no problem with pressures.Information of the device total run time is: 3 days, 18 hours, 6 minutes.The complaint allegation is not confirmed.The reported failure couldn't be replicated.

• 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: 21170235
• Report Number: 1220246-2025-09492
• Device Sequence Number: 21189590
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(11)230825(10)22302012
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 22302012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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
• Patient Sex: Unknown