BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW OUTFLOW TUBE SET W/REDEUCE TUBING

    MDR report key: 19477322 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05066
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    September 23, 2021
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867118089
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE OF THE DEVICE DUE TO DAMAGE TO THE DEVICE. THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE OF THE DEVICE DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 09/23/2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA SEMS THAT AN AR-6435 DW OUTFLOW TUBING WAS NOT WORKING PROPERLY, OUTFLOW WAS NOT DETECTED. THIS WAS DISCOVERED DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054573 DW OUTFLOW TUBE SET W/REDEUCE TUBING ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. DW OUTFLOW TUBE SET W/REDEUCE TUBING 50375953 00888867118089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown