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

Model Number CWIII ARTHROSCOPY PUMP

Device Problem Defective Device (2588)

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

Event Date 03/24/2021

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.

Event Description

It was reported that the device cannot hold the pressure.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update 03/20/21: received further information that during anterior cruciate ligament reconstruction the pump delivers irrigation fluid without any control, the pressure control sensor is defective.There has been high amount of irrigation fluid in the joint and surrounding tissue, as the pump was in continuous irrigation mode without pressure detection.The surgery was finished successfully with a new device with the same part number and the main tubing ar-6420cl.It was not necessary to switch the surgical technique or do a second surgery.No further information received.

Manufacturer Narrative

The complaint was not confirmed.The returned ar-6475 was visually inspected and show minor scratches at the top of the unit.Tubing was not returned for evaluation.Further review showed the seal was broken.The returned ar-6475 device assembled with a new ar-6410 tubing and it was tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or; (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• Brand Name: CWIII ARTHROSCOPY PUMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11692738
• MDR Text Key: 246228785
• Report Number: 1220246-2021-02929
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (y/n): N
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other