BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROLINK

    MDR report key: 15811745 · Received November 17, 2022

    Report

    Report Number
    3006891798-2022-00041
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 16, 2022
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    00812444026344
    PMA / PMN Number
    K100006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO THE MANUFACTURER TO REWORK WITH MISSING LABEL. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "THE SIDE PANEL IS MISSING ON ALL THE BOXES" WE CANNOT RELEASE THEM AS IS." NO PRODUCT WAS DISTRIBUTED TO THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417266 ARTHROLINK UHMWOE POLYBLEND BRAIDED NON-ABSORBABLE SUTURE NEEDLE GAT RIVERPOINT MEDICAL LLC HSE-2K-VIMS 22091320 00812444026344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown