BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICONIX 2TT

    MDR report key: 23137760 · Received September 24, 2025

    Report

    Report Number
    3006981798-2025-00039
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 24, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    UDI-DI
    00812444029895
    PMA / PMN Number
    K233468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NONONCONFORMITIES 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 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

    THE DEVICE WAS NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NONONCONFORMITIES 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 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. UPDATED TO CORRECT (5. LABELED FOR SINGLE USE?) YES THE DEVICE IS MARKED FOR SINGLE USE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "WHILE USING THE ICONIX 2TT SWAGED WITH THE BLACK AND WHITE SUTURE, THE SUTURE GOT SUPER FRAYED AND THE SWAGED ASPECT OF THE ANCHOR SEPARATED. THIS IS THE THIRD TIME I'VE BEEN IN A CASE WITH THIS ISSUE. WE SWITCHED TO THE BLUE ANCHOR AND IT WORKED FINE."

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "WHILE USING THE ICONIX 2TT SWAGED WITH THE BLACK AND WHITE SUTURE, THE SUTURE GOT SUPER FRAYED AND THE SWAGED ASPECT OF THE ANCHOR SEPARATED. THIS IS THE THIRD TIME I'VE BEEN IN A CASE WITH THIS ISSUE. WE SWITCHED TO THE BLUE ANCHOR AND IT WORKED FINE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642146 ICONIX 2TT 2.3MM ANCHOR WITH 1 STRAND SWAGED 2.2MM MBI RIVERPOINT MEDICAL LLC SK-ICX543 25031108 00812444029895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown