BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIALTY 4.0MM DIA X 40MM THREADED DRILL PER FILE

    MDR report key: 2831086 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02192
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HRS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING A PLANNED REVISION SURGERY, SURGEON IMPLANTED A MULTIHOLE REVISION CUP. WHILE DRILLING HOLE FOR SCREWS, DRILL BIT BROKE OFF INTO THE ACETABULUM. SURGEON STATED NOT A LOT OF FORCE USED. SURGEON WAS ASKED IF HE WAS GOING TO REMOVE THE DRILL BIT, HE STATED HE WILL NOT REMOVE IT AS IT WOULD MEAN REMOVING THE CUP AND OTHER SCREWS, AND WHEN REMOVING THE DRILL BIT IT WOULD REMOVE A LARGE AMOUNT OF BONE WITH IT. HE WAS THEN ASKED IF THE DRILL BIT WAS PROTRUDING OUT THE CUP. HE REPLIED IT WAS WELL WITHIN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY 4.0MM DIA X 40MM THREADED DRILL PER FILE INSTRUMENT HRS STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other