BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, SOLERA STANDARD DRIVER

    MDR report key: 2152305 · Received June 23, 2011

    Report

    Report Number
    1723170-2011-01142
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED FOR REPLACEMENT PART. UPON EVALUATION OF RETURNED ITEMS, MEDTRONIC MECHANICAL ENGINEER HAS DETERMINED THAT THESE PARTS ARE FULLY FUNCTIONAL. NO PROBLEM FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC MECHANICAL ENGINEER REPORTED AN ISSUE WITH THE NAVLOCK SOLERA DRIVER DURING A CASE. THE ENGINEER STATED THAT THE TIP OF THE SOLERA SCREW DRIVER BROKE OFF IN THE SCREW HEAD AND THE NAVLOCK TAP WAS LOCKED IN THE NAVLOCK TRACKER HANDLE AND IT WOULD NOT RELEASE. A 6.5 X 50 SOLERA SCREW WAS BEING USED IN A PT WITH SCLEROTIC BONE. THE NAV SOLERA DRIVER (CANNULATED) BROKE IN THE INTERNAL TORX OF THE SCREW. IN ADDITION, WHEN USING THE 5.5 NAV SOLERA TAP, THEY HAD TROUBLE GETTING IT TO ENGAGE IN THE BONE (DUE TO THE HARD BONE) SO THEY MALLETED THE BACK END OF THE SOLERA RATCHET HANDLE. WHEN THEY TRIED TO REMOVE THE HANDLE, THE HANDLE WAS STUCK ONTO THE DRIVER. AFTER THE CASE, THE REP WAS ABLE TO REMOVE THE HANDLE BUT IT TOOK SIGNIFICANT EFFORT (MORE THAN SHOULD BE REQUIRED). NO IMPACT ON PT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, SOLERA STANDARD DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 101221

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR