BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER SOLERA RDN MAST

    MDR report key: 3526286 · Received December 18, 2013

    Report

    Report Number
    1723170-2013-01077
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 26, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE ASSESSMENT WAS ABLE TO DETERMINE THAT TESTING HAD BEEN PERFORMED DURING THE DEVELOPMENT OF THE SCREWDRIVERS THAT DEFINED THE TORQUE REQUIRED TO INSERT A SCREW IN A PROPERLY TAPPED HOLE AND VERIFIED THAT THE SCREWDRIVERS WERE CAPABLE OF MEETING THE TORQUE REQUIREMENTS. THE ROOT CAUSE WAS IDENTIFIED AS TORQUE APPLIED TO THE SCREWDRIVERS BEYOND THE STRENGTH LIMIT OF THE SCREWDRIVERS, MOST LIKELY THE RESULT OF TRYING TO INSERT A LARGE DIAMETER SCREW INTO BONE THAT HAD BEEN UNDERTAPPED (EITHER IN DIAMETER OR DEPTH) OR TRYING TO INSERT A LARGE SCREW INTO HARD BONE.

    Additional Manufacturer Narrative · 1

    MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE TIP OF THE INSTRUMENT IS TWISTED AND BROKEN OFF. THERE ARE ALSO SEVERAL IMPACT MARKS AT THE HANDLE END OF THE INSTRUMENT. MECHANICAL FAILURE, BROKEN PIECES, DIRECTLY CAUSED THIS EVENT. ISSUE COULD NOT BE REPLICATED. BASED ON TOXICOLOGICAL RISK ASSESSMENT OF THE MATERIAL IN THE DEVICE, THE POTENTIAL HEALTH RISK RESULTING FROM EXPOSURE TO A FRAGMENT OF THE DEVICE IS CONSIDERED TO BE NEGLIGIBLE. PER MEDTRONIC NAVIGATION, INC. MECHANICAL DESIGN ENGINEER

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE TIP OF THE SOLERA REDUCTION DRIVER BROKE OFF IN THE SCREWHEAD. THE SURGEON DID MAKE AN ATTEMPT WITH BAYONETS TO PRY OUT THE BROKEN DRIVER TIP THAT WAS ATTACHED TO THE PERC SCREW, WITHOUT SUCCESS. THE SURGEON CONTINUED THE PROCEDURE USING A SECOND NAVIGATED SOLERA DRIVER. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660906 SCREWDRIVER SOLERA RDN MAST NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 130409

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR