BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURISTIK

    MDR report key: 4209168 · Received September 12, 2014

    Report

    Report Number
    3004154314-2014-00001
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HSD
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED THE NANOFX GUIDE WIRE INTO THE SUBCHONDRAL BONE SUCCESSFULLY TWICE. ON THE THIRD ATTEMPT, THE NANOFX GUIDE WIRE BECAME STUCK IN THE BONE. THE SURGEON APPLIED FORCE AND THE NANOFX GUIDE WIRE BROKE OFF IN THE BONE. THE SURGEON OPTED TO LEAVE THE BONE TIP OF THE NANOFX GUIDE WIRE IN THE BONE, FEELING IT REPRESENTED A MINIMAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566495 PLEURISTIK GUIDE WIRE HSD ARTHROSURFACE, INC. FURS-2101 75CD0529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other