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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Pressure Problem (3012)

Patient Problem Swelling/ Edema (4577)

Event Date 04/27/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that an ar-6480 pump that was going full boar on inflow side today and blew the patients knee up.There were no kinks in the line and everything was hooked up correctly.The sales rep disconnected the inflow (ar-6411) then re-attached after power cycle it began to work.After restart the pump went to overpressure.Requested additional information.

Manufacturer Narrative

The complaint allegation was not confirmed.(1) unpackaged ar-6480 dualwave arthroscopy fluid management system was returned for investigation.The returned device was visually inspected and damage to the screen was noted.Further review of the pump sub-assembly and components showed no functional issues with the latch door or tubing connector.The returned device was assembled with a new ar-6410 arthroscopy pump tubing and was tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and functioned as intended with no error messages and no audible alarms triggered.A clamp test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an over pressure failure on the allege pump, and to verify if an error message and/or audible alarm will be triggered.The results of the clamp test indicate the pump triggered an alarm and provided an error.This behavior is expected.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• 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: 14407345
• MDR Text Key: 291728808
• Report Number: 1220246-2022-04924
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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: 13395245
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other