BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDARTIS APTUS

    MDR report key: 4466131 · Received January 23, 2015

    Report

    Report Number
    MW5040446
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 15, 2015
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING AN OPEN REDUCTION INTERNAL FIXATION OF RIGHT EXTRA-ARTICULAR RADIUS FRACTURE. THE SURGEON WAS USING MEDARTIS APTUS HAND PLATES AND SCREWS TO FIXATE THE FRACTURE. AS THE 2.5MM NON-LOOKING SCREW WAS BEING TIGHTENED, THE SCREW HEAD BROKE OFF OF THE SCREW. THE SCREW WAS SIGNIFICANTLY IMBEDDED IN THE BONE AND DID NOT DEMONSTRATE ANY TYPE OF LOOSENING, SO IT WAS LEFT IN PLACE. IT IS THE SURGEON'S OPINION THAT THIS SHOULD NOT HAVE ANY CLINICAL CONSEQUENCE FOR THIS PT. A MFR'S REP WAS PRESENT DURING THE CASE AND IS AWARE OF THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53851 MEDARTIS APTUS APTUS HAND HRS MEDARTIS, INC. HAND 2.0/2.3

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR