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

Model Number SYNERGY CW4 ARTHROSCOPY PUMP

Device Problems Failure to Pump (1502); Output Problem (3005)

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

Event Date 09/11/2023

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

It was reported that the device does not pump fluid.There was no harm for patient, operator or third party reported.No further information was received.

Manufacturer Narrative

Complaint is not confirmed.One un-packaged ar-6485 synergy cw4 arthroscopy pump sn (b)(6) was returned for investigation.The returned device was assembled with an ar-6430 lot# 40067370 and ar-6421 lot# 65708975 pump tubing and was 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.Upon letting the pump run for 63 minutes, no issues were observed.The device inflow/outflow works as intended.A clamp test was performed as a safety check to ensure the sensor system works appropriately.After the air had been purged from the tubing, the clamp was closed at the patient end of the tubing.The machine triggered an alarm, and the inflow rollers stopped.This is the expected behavior.No problem found.The reported failure could not be reproduced.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17915135
• MDR Text Key: 325419986
• Report Number: 1220246-2023-08147
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: 00888867251182
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 22212009
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1