BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER SOLERA RDN MAST

    MDR report key: 3800735 · Received May 8, 2014

    Report

    Report Number
    1723170-2014-00457
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 17, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, WAS ABLE TO REPLICATE THE ISSUE WITH THE SAME DRIVER INSTRUMENT. ALL OTHER INSTRUMENTATION WERE FOUND TO BE ACCURATE. (B)(4) 2014 - A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED.MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE TIP OF THE INSTRUMENT IS TWISTED AND BROKEN OFF. MECHANICAL FAILURE, BENT INSTRUMENT TIP DIRECTLY CAUSED EVENT.

    Additional Manufacturer Narrative · 1

    THE FORMAL INVESTIGATION 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 THAT HAD BEEN UNDERTAPPED (EITHER IN DIAMETER OR DEPTH) OR TRYING TO INSERT A LARGE SCREW INTO HARD BONE.

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION. THE MOST LIKELY ROOT CAUSE WAS A HARDWARE ISSUE AND USE ERROR SINCE IT WAS REPORTED THAT THE INACCURACY DURING TESTING WAS ATTRIBUTED TO SELECTING THE INCORRECT DRIVER (STANDARD VS. REDUCTION) AND THE TIP OF THE DRIVER WAS BENT WITH THE SCREW NOT INTERFACING WELL WITH THE DRIVER. THE DRIVER WAS ALSO PREVIOUSLY REPORTED ON THE INITIAL 3500A TO HAVE DAMAGE AT THE TIP. THIS MAY HAVE CONTRIBUTED TO THE INACCURACY BUT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE, THE SURGEON ALLEGED THE NAVIGATION SYSTEM WAS INACCURATE. THE SURGEON TOOK A 3D SPIN WITH THE IMAGING SYSTEM, NOTED THAT THE LEFT/RIGHT WERE OPPOSITE ON THE EXAM THAN WHAT WAS EXPECTED, AND THE SYSTEM WAS 5 TO 10MM INACCURATE. THE SURGEON PLACED THE L5 AND S1 SCREWS, HOWEVER, FOUND THE SCREWS WERE MEDIAL IN THE PATIENT. THE SURGEON REMOVED THE L5 SCREW FROM THE ANATOMY AND RE-ADJUSTED THE S1 IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279047 SCREWDRIVER SOLERA RDN MAST NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111208

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention