BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 19912342 · Received August 5, 2024

    Report

    Report Number
    3006981798-2024-00040
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 5, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087215
    PMA / PMN Number
    K203740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE REPORT COULD NOT SUBSTANTIATED. THERE IS A POSSIBILITY OF USING THE INCORRECT SURGICAL METHOD FOR IMPLANTING THE INSERTER. FURTHERMORE, IF THE DRILL CHANNEL IS TOO SMALL OR THE BONE QUALITY IS NOT OF ACCEPTABLE FORM, THIS KIND OF FAILURE IS POSSIBLE. A CAUSE FOR THE EVENT CANNOT 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 HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL 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 FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "THE TIP OF INSERTER WAS FRACTURED DURING USE, AND THE FRACTURED PIECE OF INSERTER HAS BEEN REMAINING IN THE PATIENT'S BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265300 JUGGERKNOT SOFT ANCHOR SINGLE LOADED IMPLANT WITH NEEDLES MBI RIVERPOINT MEDICAL LLC CM-99145BRN 23092723 00810020087215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown