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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Intermittent Loss of Power (4016)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is not confirmed.There are no signs of significant damage found.

Event Description

It was reported the ar-6480 pump outflow will not stay on.Additional information 7/15/2021.It was reported during a hip procedure the ar-6480 pump, would not stay on, we continuously have to hit run.The issues are coming on the shaver connects.The screen will head blank nonstop and the outflow tubing goes back-and-forth versus circulates all the way around.The case was completed by someone continuously standing at the pump to get it to run long enough for the surgeon to shave the area needed.

• 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: 18246683
• MDR Text Key: 329487164
• Report Number: 1220246-2023-09044
• 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
• Report Date: 12/01/2023

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: 21811015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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