BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTUS FOOT SYSTEM

    MDR report key: 10808791 · Received November 9, 2020

    Report

    Report Number
    10808791
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    September 28, 2020
    Report Date
    September 30, 2020
    Manufacturer
    MEDARTIS AG, C/O PAXMED INTERNATIONAL, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGERY, THE SURGEONS WERE USING THE SCREWDRIVER AND THE TIP OFF 2 SCREWDRIVERS BROKE WHILE IN USE. THE SCREWDRIVER TIP BROKE IN THE PATIENT. BROKEN PIECES WERE THEN TAKEN OUT OF THE PATIENT AND USED X-RAY TO CONFIRM THAT ALL PIECES WERE REMOVED. ATTENDING/FELLOW SURGEONS AWARE, NOTE WRITTEN CONFIRMING NOTHING RETAINED IN PATIENT, BROKEN INSTRUMENT SHOWN/GIVEN TO OPERATING ROOM STAFF AND NO HARM TO THE PATIENT CAUSED. MANUFACTURER RESPONSE FOR MEDARTIS DRIVER BLADE, (BRAND NOT PROVIDED) (PER SITE REPORTER). SCREW DRIVERS WILL BE REPLACED IN IMPLANT TRAY WITH NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278047 APTUS FOOT SYSTEM SCREW, FIXATION, BONE HWC MEDARTIS AG, C/O PAXMED INTERNATIONAL, LLC 1614578018175283

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA