MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/22/2020

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 it was initially noted that the knee could not be fully flexed during the surgery.It was discovered that the whole of the patient's thigh distal to the tourniquet was "solid", "turgit", "taut".Approx.1.5 liter of fluid had been forced into the tissues under pressure.The fluid was being run through the dualwave console, main pump tubing and patient extension tubing.There had been an audible warning of high pressure prior to surgical intervention but this had been investigated fully and the pump appeared to be working correctly with no other alarms.Decisions had to be made regarding further emergency surgical intervention due to compression in the thigh.An early discovery and prompt action by the surgical and anaesthetic team meant that no further emergency treatment was needed.Procedure performed was a revision acl reconstruction using patella tendon graft with partial medial menisectomy and lateral extra-articular tenodesis.The procedure was completed successfully, however, surgical technique had to be changed to limit use of diathermy.Decisions had to be made regarding choice of surgical procedure as the original intended operation may not have been possible.

Manufacturer Narrative

The complaint was not confirmed.The returned pump was visually inspected and showed a minor scratches at the face of the pump, no other physical damage on the unit was noticed.Further review of the pump sub-assembly and components, showed no issues with the latch door or tubing connector.The pump was assembled with a new ar-6410 tubing, and then 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: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9756810
• MDR Text Key: 192625006
• Report Number: 1220246-2020-01736
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other