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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Decrease in Pressure (1490)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint allegation was not confirmed.The returned device was visually inspected, and no problems were noted with the device.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 no error messages and no audible alarms were 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 pump, and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate the pump triggered an alarm and the rollers stopped moving.This is expected behavior.When the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected.The review of complaint records for serial number (b)(6) shows that the device has no previous complaints.

Event Description

It was reported that the pressure and the flow rate was too low while flushing.There was no harm for patient, operator or third party reported.No further information received.24-nov-2022 update (b)(6).Further information were provided that the reported event occurred one day earlier on the (b)(6) 2022.The reported event occurred during an arthroscopic knee surgery.It was further reported that arthrex tubing was used and the device was set to the knee mode with the setting set to 60.The surgery was finished successfully without patient harm.

• 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: 18257852
• MDR Text Key: 329620779
• Report Number: 1220246-2023-09126
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 22108017
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1