BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 16857520 · Received May 2, 2023

    Report

    Report Number
    3006981798-2023-00023
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 17, 2023
    Report Date
    November 20, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087116
    PMA / PMN Number
    K203740
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES NOTED DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THE INSERTER RAW MATERIAL SPECIFICATIONS WERE REVIEWED AND ALL REQUIREMENTS WERE MET PRIOR TO RELEASE. NO INSERTERS WERE AVAILABLE FROM THE LOT USED IN THIS DEVICE. A CAUSE FOR THE EVENT HAS NOT BEEN ESTABLISHED AND THE REPORT CANNOT BE SUBSTANTIATED. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED AND WAS SENT TO THE SUPPLIER FOR FURTHER ANALYSIS. THE SUPPLIER EVALUATION INDICATED NO MANUFACTURING DEFECTS ON THE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. 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, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT PULLED OUT UNINTENDED ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING NORMAL USAGE, AND IT WAS CONFIRMED THAT THE TIP OF INSERTER WAS FRACTURED. THERE IS THE POSSIBILITY THAT THE FRACTURED PIECE OF INSERTER HAS BE REMAINED IN THE PATIENT'S BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318537 JUGGERKNOT SOFT ANCHOR FIXATION DEVICE MBI RIVERPOINT MEDICAL LLC CM-99114BN 21030829 00810020087116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown