BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" DRILL W/O STOP - 2/PKG

    MDR report key: 1082456 · Received July 22, 2008

    Report

    Report Number
    2249697-2008-00214
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING THE TKA SURGERY, WHEN THE SURGEON WAS DRILLING A HOLE IN THE PT'S TIBIA TO FIX BY THE SCREW, THE 1/8" DRILL WAS BROKEN. THE SURGEON REMOVED THE FRAGMENT OF THE DRILL FROM THE PT'S TIBIA. THE PT HAS NOT HAD ANY HEALTH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1/8" DRILL W/O STOP - 2/PKG INSTRUMENT HTW STRYKER ORTHOPAEDICS MAHWAH NA SC7434

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other