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 01/25/2024

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 01/25/2024, it was reported by a facility representative via (b)(4) that an ar-6485 synergy cw4 arthroscopy pump was weak and slow compared to other units in the section.This occurred during a case, with no patient effect reported.

Manufacturer Narrative

Complaint is not confirmed.One unpackaged ar-6485 dualwave arthroscopy fluid management system was returned for investigation.The returned device was assembled with a new ar-6411/ar-6421 arthroscopy pump tubing.Upon functional testing, the pump was turned on and tested under normal use conditions to find if the issue reported could be reproduced, and no issues were found with the device.The device worked as required.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.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.Functional testing with the pressure calibrator found no pump pressure issues.The pump was supplied with 100mmhg and 200mmhg of pressure and displayed the correct reading for each.No problem found.Visual evaluation found that the inflow roller housing door had cracked.The review of complaint records for serial number (b)(6) shows that the device has no previous complaints.The original warranty seal was present and completed.The manufacturing date of the device is 2017-06-21.No problem found.Refer to investigation photos.Complaint is not confirmed.

• 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: 18690946
• MDR Text Key: 335207610
• Report Number: 1220246-2024-00918
• Device Sequence Number: 1
• Product Code: HRX
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 21706032
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2017
• 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