BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICONIX KNOTLESS

    MDR report key: 17935693 · Received October 13, 2023

    Report

    Report Number
    3006981798-2023-00067
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 8, 2023
    Report Date
    November 13, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00840277402172
    PMA / PMN Number
    K231278
    Removal / Correction Number
    300698179810/25/2023001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND THEREFORE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. INVESTIGATION IS STILL ONGOING. NO CAUSE FOR THE EVENT HAS BEEN ESTABLISHED AT THIS TIME. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVER POINT MEDICAL OR ITS EMPLOYEES THAT RIVER POINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVER POINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVER POINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND THEREFORE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. INVESTIGATION DETERMINED THAT THE INSTRUCTIONS FOR USE NEEDED MORE CLARITY. 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, "PILOT HOLE MADE WITH 1.8MM STEINMANN PIN. IMPLANT SUCCESSFULLY INSERTED BUT UPON ATTEMPTED SET/DEPLOYMENT OF THE ANCHOR, IT PULLED OUT. NO PORTION OF THE IMPLANT REMAINED IN THE PATIENT. SUBSEQUENTLY, A CINCH LOCK SS (B)(6) ANCHOR WAS ABLE TO BE UTILIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748863 ICONIX KNOTLESS FIXATION DEVICE MBI RIVERPOINT MEDICAL LLC 3911-714-520 23080433 00840277402172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown