BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SOLERA RDN MAST

    MDR report key: 2963803 · Received February 15, 2013

    Report

    Report Number
    1723170-2013-00094
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    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

    MEDTRONIC INSPECTION OF RETURNED SUSPECT SOLERA SCREWDRIVER FINDS THE 4MM OF THE TIP HAS BEEN BROKEN OFF AND IS ALSO TWISTED. THIS MECHANICAL PROBLEM DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A PROCEDURE, A SOLERA MAST REDUCTION DRIVER TIP BROKE OFF IN THE SCREW; THIS OCCURRED DURING INSERTION INTO VERY SCLEROTIC BONE. THE SURGERY WAS COMPLETED USING A NON-REDUCTION SOLERA DRIVER WHILE CONTINUING 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
    68261 SCREWDRIVER SOLERA RDN MAST NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 121114

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR