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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

Event Description

It was reported that the were malfunctions with 3x ar-6480 pumps.Serial number (b)(6) experienced too much fluid going into the joint and the pump did not respond to controls.Serial number (b)(6) experieced no flow, the pump wouldn't run.Unsure if error was present.Serial number (b)(6) - experieced excessive pulling of water and it was making a loud noise.

Manufacturer Narrative

The complaint is confirmed.The inflow motor is loud and grinding, measured at 82 db.This is not attributed to a manufacturing defect.However, this is attributed to a normal wear-out since the unit has been in service for 51 months.The unit passed other bench tests during the evaluation.

• 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: 18245180
• MDR Text Key: 329433847
• Report Number: 1220246-2023-09029
• 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: 10128088
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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