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

Model Number	SYNERGY CW4 ARTHROSCOPY PUMP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged ar-6485 synergy cw4 arthroscopy pump serial number: (b)(6) was received for investigation.The returned device was visually inspected, and wear and tear was noted to the device with scratches and nicks observed on the top panel of the housing.The returned device was assembled with a known good ar-6410 and ar-6430 pump tubing and was tested and evaluated under normal conditions to see if the failure could be reproduced.The pump was connected to the power and turned on.After selecting the desired pressure preset, the run button was pressed to start the machine.The device was run for 35 minutes with no issues.The returned ar-6485 synergy cw4 arthroscopy pump was observed to respond and function as intended with no sudden changes in pressure noted.No problem found.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.This behavior is expected¿no problem found.Pressure testing evaluation with the pressure calibrator set at 100 and 200 mmhg gave the pump pressure results of 45 and 91, respectively.These results indicated no problem with pressures.The device information was read, and the total run time for the device was indicated to be 8 days, 5 hours, 23 minutes.It was noted during the test that the pump motor/rotating parts made a loud noise when running.The cause of this can be attributed to wear and tear of the motor, which is exhibited in the noisy motor and caused by extended usage in the field¿ date of manufacture: 20-jun-2018.Refer to investigation photos.
Event or Problem Description
On 01/30/2025, a sales representative reported via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump was experiencing inaccurate pressure readings.

• 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: 21393789
• Report Number: 1220246-2025-00504
• Device Sequence Number: 18258220
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(11)180620(10)21707041
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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: 21707041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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