BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 14718554 · Received June 16, 2022

    Report

    Report Number
    3006981798-2022-00013
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    April 12, 2022
    Report Date
    June 16, 2022
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087154
    PMA / PMN Number
    K203740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DHR FOR THE LOT WAS PERFORMED AND NO ISSUES WERE NOTED DURING MANUFACTURING. SAMPLES FROM OTHER BATCH RETAINED BY THE MANUFACTURER WILL BE TESTED FOR FINISHED GOODS TESTING. 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 PART 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, "JUGGERKNOT WITH BROADBAND TAPE FAILED, PULLED OUT OF BONE WHILE "TIEING" KNOTS FOR SLAP REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313159 JUGGERKNOT SOFT ANCHOR SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER MBI RIVERPOINT MEDICAL LLC CM-99115B 21022423 00810020087154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown