BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 10MM DRILL

    MDR report key: 2268030 · Received September 7, 2011

    Report

    Report Number
    9617544-2011-00305
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HTW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION. THIS MDR OCCURRED DURING THE SAME EVENT FILLED WITH MEDWATCH NUMBERS 9617544-2011-00304 AND 9617544-2011-306.

    Description of Event or Problem · 1

    AT C6-7 LEVEL, ADJACENT TO PREVIOUS C4-6 FUSION, SURGEON USED CAGE WITH 3.5X12 ST SCREWS. UPON DRILLING SECOND HOLE FOR THE PROXIMAL SCREW, THE DRILL BIT FRACTURED APPROXIMATELY TO TWO THIRDS FROM THE TIP WHEN IT FIRST PENETRATED THE CORTICAL SHELL. SURGEON REMOVED THE DISTAL SCREW AND CAGE AND RETRIEVED BROKEN TIP. THE CAGE WAS REINSERTED WITH A RESCUE SCREW. SURGEON RE-DRILLED THE PROXIMAL SCREW HOLE WITH A 12MM DRILL BIT. THE DRILL BIT TIP BROKE IN THE SAME FASHION AS THE OTHER. WHEN REMOVING THE CAGE WITH THE AIO GUIDE, THE INNER SHAFT ON THE DRILL GUIDE BROKE. THE TIP OF THE DRILL GUIDE IS STILL EMBEDDED IN THE CAGE. THE PATIENT RECEIVED ANOTHER CAGE WITH FIXATION. DELAY IN SURGERY, SURGEON KEPT PATIENT OVERNIGHT IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR C 10MM DRILL INSTRUMENT HTW STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization