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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem No Display/Image (1183)

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

Event Date 04/05/2022

Event Type  malfunction  

Event Description

It was reported that there is a loose connection from time to time with tubing (ar-6420).The device has also turned black during surgery.There was no harm for patient, operator or third party.Update swit (b)(6) 2022: the surgery could be finished successfully with the same pump and tubing.

Manufacturer Narrative

The complaint allegation was not confirmed.One ar-6480 dualwave arthroscopy fluid management system was returned for investigation.The returned device was visually inspected and no apparent damage was noted.Further review of the pump sub-assembly and components showed no 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.The complaint tube set was not sent for evaluation.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 confirmed the pump triggered an alarm and provided an error as intended/expected.The pump operated under normal conditions for two hours.Review of complaint records for serial number n13840f18 showed that the device has no previous complaints.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE AND ACCESSORIES
• 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: emily shafer ; 8009337001
• MDR Report Key: 18158572
• MDR Text Key: 328362597
• Report Number: 1220246-2023-08774
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K083707
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Device Lot Number: 21805038
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1