BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERKNOT SOFT ANCHOR

    MDR report key: 19084312 · Received April 10, 2024

    Report

    Report Number
    3006981798-2024-00029
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 9, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00840277402431
    PMA / PMN Number
    K203740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. 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 BE SUBSTANTIATED. 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: "ALL-SUTURE ANCHOR INDICATED FOR RCR REPAIR. ON (B)(6) 2024 DR. (B)(6) , USED THE PRODUCT ABOVE, AND IT WAS UNSATISFACTORY. AS DR. (B)(6) WAS HOLDING THE ANCHOR THE HUMERAL HEAD AND HIS FELLOW WAS APPLYING FORCE WITH A MALLET, THE ANCHOR INSERTER BENT AND BROKE ON TWO OCCASIONS. THE BEND WAS SIGNIFICANT LEFT THE PRODUCT DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914149 JUGGERKNOT SOFT ANCHOR SELF PUNCHING TRIPLE LOADED IMPLANT MBI RIVERPOINT MEDICAL LLC SP99529B 23081820 00840277402431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown