BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SOLERA RDN MAST

    MDR report key: 2881772 · Received December 20, 2012

    Report

    Report Number
    1723170-2012-00748
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2012. MEDTRONIC INVESTIGATION OF RETURNED DEVICE FINDS THERE ARE IMPACT DIVOTS ON THE BACK END OF THE INSTRUMENT NOT ALLOWING INSERTION INTO A NAVLOCK. THE TIP OF THE DRIVER IS TWISTED AS WELL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SURGERY, USING A 4.75 SOLERA REDUCTION SCREWDRIVER, THE NAVLOCK LOCKED TIGHT TO THE DRIVER AND WOULD NOT RELEASE OR ALLOW FOR THE NAVLOCK TO SPIN FREELY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER SOLERA RDN MAST NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 110812

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR