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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Suction Failure (4039)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is not confirmed.It was observed during the evaluation that two bumpers and four power cables are missing.

Event Description

Outflows not working- outflows randomly not sucking.Customer observed that roller was not working.

• 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: 18246649
• MDR Text Key: 329486875
• Report Number: 1220246-2023-09043
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 06/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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