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	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/21/2025, a facility representative reported via (b)(4) that an ar-6485 synergy cw4 arthroscopy pumps pressure will jump intermittently and the hand control will not connect to the pump.This occurred during a case with no patient harm.
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.The complaint allegation is not confirmed.The reported failures cannot be reproduced.One unpackaged ar-6485 synergy cw4 arthroscopy pump, serial number (b)(6), was returned for evaluation.Visual evaluation observed regular signs of wear and tear.No cosmetics issues were noted.The returned device was assembled with ar-6411 lot# 65043383 and ar-6421 lot# 65708975 pump tubing, and an ar-6482 dualwave remote.It was tested and evaluated under normal use conditions to see if the reported issue(s) could be reproduced.The remote was connected to the pump, and when the keypad buttons were pressed, it was noted that the pump responded without issues.The device is working as intended.(refer to the video).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 46 minutes without any issues.No changes in pressure were noted during the test.The device pressure remained stable, with no changes or intermittent flow pressure occurring during the run.The device was connected to the synergy recession console, which was also connected to a handpiece and a footswitch to test for any malfunction.The device did not show any malfunction.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 45 and 91, respectively.These results indicated no problem with pressures.It was noted during the test that the pump motor/rotating parts made a loud noise when running at high speed.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¿device manufacture date 2021.Device total run time information.9 days, 18 hours, 46 minutes.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed.The reported failures cannot be reproduced.One unpackaged ar-6485 synergy cw4 arthroscopy pump, serial number (b)(6), was returned for evaluation.Visual evaluation observed regular signs of wear and tear.No cosmetics issues were noted.The returned device was assembled with ar-6411 lot# 65043383 and ar-6421 lot# 65708975 pump tubing, and an ar-6482 dualwave remote.It was tested and evaluated under normal use conditions to see if the reported issue(s) could be reproduced.The remote was connected to the pump, and when the keypad buttons were pressed, it was noted that the pump responded without issues.The device is working as intended.(refer to the video).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 46 minutes without any issues.No changes in pressure were noted during the test.The device pressure remained stable, with no changes or intermittent flow pressure occurring during the run.The device was connected to the synergy recession console, which was also connected to a handpiece and a footswitch to test for any malfunction.The device did not show any malfunction.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 45 and 91, respectively.These results indicated no problem with pressures.It was noted during the test that the pump motor/rotating parts made a loud noise when running at high speed.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¿device manufacture date 2021.Device total run time information.9 days, 18 hours, 46 minutes.

• 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: 21356853
• Report Number: 1220246-2025-00384
• Device Sequence Number: 8451567
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(10)15030331
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/22/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 09/18/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/10/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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