BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 18468946 · Received January 8, 2024

    Report

    Report Number
    3006981798-2024-00002
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    November 9, 2023
    Report Date
    January 8, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087192
    PMA / PMN Number
    K203740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. A REVIEW OF STERILIZATION RECORDS FOR THE LOT SHOWED THAT ALL PRODUCTS MET STERILIZATION AND POUCH SEAL REQUIREMENTS PRIOR TO RELEASE. THE REPORT COULD NOT BE SUBSTANTIATED AND A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. 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, "A WOUND INFECTION OCCURRED IN 2 DIFFERENT PATIENTS APPROX. 4 WEEKS AFTER THE INSERTION OF JUGGERKNOT ANCHORS. BOTH PATIENTS HAVE THE SAME LOT NUMBER. IT IS NOT CLEAR WHICH OF THE 4 ANCHORS CAUSED THE PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600672 JUGGERKNOT SOFT ANCHOR FIXATION DEVICE MBI RIVERPOINT MEDICAL LLC CM-99129BN 23041913 00810020087192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other