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

Model Number SYNERGY CW4 ARTHROSCOPY PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Swelling/ Edema (4577)

Event Date 02/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, it was reported by an arthrex employee via sems that an ar-6485 synergy pump caused swelling, and infiltration in a knee.This occurred during an acl procedure on (b)(6) 2023, they were able to reduce the edema, and complete the case using the same pump.Additional information was provided on 02/27/2023, it was reported that in this surgery the reference pipe ar-6410 was used.The settings were in the standard for knee arthroscopy with pressure between 40/45.All pipe fittings were in accordance with established standards, all fitted according to the usual standard.During surgery, no audible alarm was activated, and the pressure was between 40 and 45 but seemed to be at 60% more than the one reported on the monitor.Could not register photos and videos.There is a large extravasation, which provided a large swelling both in the knee and in the thigh part near the knee.At the end of the surgery, the doctor drained the serum making understanding, and also left the patient with a 3.2 mm portovac drain.When the doctor realized the size of the swelling in the patient's knee, he decided to do the remainder of the surgery without using the connected tubes in their pump he asked to remove the tubes from the system and only used the serum by elevation.".

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.

• 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: 16511736
• MDR Text Key: 310954414
• Report Number: 1220246-2023-06404
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: 00888867251182
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• 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: 22105021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2023
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other