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

Model Number SYNERGY CW4 ARTHROSCOPY PUMP

Device Problem Defective Device (2588)

Patient Problem Swelling (2091)

Event Date 02/03/2020

Event Type  Injury  

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.

Event Description

It was reported that during an acl procedure, the pump, jls-jpump, become uncontrollable and the fluid was flowing continuously.This event caused the patients leg to swell.The surgeon then stopped the pump and converted to gravity flow.The case was completed by using another pump without any further issue.After the procedure was completed, an echo test was performed on the patient and no harm was detected.Further information requested.**additional information provided 2/6/20: two perfusion needles were inserted into the thighs of the patient in order to removed the excess fluid.The surgeon also converted to gravity tubing in order to complete the case.

• Brand Name: SYNERGY CW4 ARTHROSCOPY PUMP
• Type of Device: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 9750634
• MDR Text Key: 190135440
• Report Number: 1220246-2020-01698
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYNERGY CW4 ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6485
• Device Lot Number: 10233682
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other