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

Model Number SYNERGY CW4 ARTHROSCOPY PUMP

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 03/18/2024, it was reported by a sales representative via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump began fluctuating pressure and flow without anything being done.This occurred during a case where the rinse or lavage function was not pushed, and the pressure was not adjusted.The pump was changed out and the case continued with no patient harm.

Manufacturer Narrative

Additional information: -complaint was not confirmed.The complaint allegation failure could not be reproduced.-one unpackaged ar-6485 synergy cw4 arthroscopy pump serial number (b)(6) was returned for evaluation.-the returned device was visually inspected, and no problems were identified.-the returned device was assembled with an ar-6411 lot# 73511090 and ar-6421 lot# 65708975 pump tubing and was tested and evaluated under normal use conditions to see if the issue 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 upon letting the pump run for 74 minutes with no issues.No changes in the pressure were noted during the time the machine was tested, and the pump consistently maintained at 49-50 with no sudden changes in pressure.-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 46 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.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 2018.-refer to investigation photos.

• Brand Name: SYNERGY CW4 ARTHROSCOPY PUMP
• Type of Device: 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: 19067351
• MDR Text Key: 340170732
• Report Number: 1220246-2024-01896
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: 00888867251182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNERGY CW4 ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6485
• Device Lot Number: 21808033
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1