BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 16742881 · Received April 14, 2023

    Report

    Report Number
    3006981798-2023-00018
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 3, 2023
    Report Date
    November 20, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00810020087215
    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

    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 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.

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED FOR EVALUATION, WHICH IS IN PROGRESS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. THE INVESTIGATION IS STILL ONGOING AND THE EVENT HAS NOT BEEN SUBSTANTIATED. A CAUSE FOR THE EVENT HAS NOT BEEN 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 FOUND THAT THE SOMETHING HAS BE REMAINED IN THE PATIENT'S BODY WHEN THE SURGEON CHECKED THE X-RAY PHOTO OF THE PATIENT AFTER THE SURGERY. THE SURGEON CHECKED THE COMPLAINT PRODUCT, HE FOUND THAT THE TIP OF INSERTER OF THE COMPLAINT PRODUCT WAS FRACTURED. THIS INCIDENT DIDN'T BE NOTICED DURING THE SURGERY. THE SURGEON SAID THE SURGERY DATE IS UNDECIDED, BUT THE SURGERY OF REMOVING THE FRACTURED PIECE OF INSERTER IS PLANNED TO BE PERFORMED AFTER ABOUT A HALF YEAR TO A YEAR LATER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901368 JUGGERKNOT SOFT ANCHOR FIXATION DEVICE MBI RIVERPOINT MEDICAL LLC CM-99145BRN 22030924 00810020087215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention