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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problems Difficult to Insert (1316); Increased Pump Speed (1501); Pumping Problem (3016)

Patient Problem Swelling/ Edema (4577)

Event Date 03/25/2021

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 during an acl reconstruction on the right knee of a (b)(6) year old patient, the pump accelerated resulting in increased fluid to the knee.The pump was set at default 35 and increased to 120.The surgeon attempted to place a second trocar into the joint but it would not insert due to the pressure.An unplanned fasciotomy was done to relieve the pressure; the case was completed without the pump.The patient was admitted for evaluation.

Manufacturer Narrative

The complaint was not confirmed.The returned pump was visually inspected and showed no physical damage on the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.Tub set was not returned for evaluation.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: 11648365
• MDR Text Key: 244866933
• Report Number: 1220246-2021-02885
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 10068203
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 06/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other