BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 3389806 · Received October 7, 2013

    Report

    Report Number
    0001811755-2013-02425
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THIS DEVICE WAS REUSED AT THE HOSPITAL. THE LABEL FOR THIS PRODUCT, 4200-355-737 REV A CONTAINS THE WARNING "DO NOT USE EXCESSIVE FORCE¿. THE LABEL ALSO HAS A SYMBOL FOR "DO NOT REUSE". DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 FEMORAL NAIL SURGERY THE TIP OF THE DRILL BIT BROKE. THE SURGEON WAS UNABLE TO REMOVE THE TIP OF THE BROKEN DRILL BUT FROM THE PATIENT'S BONE. IT WAS CONFIRMED THAT THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE DELAY. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON CONFIRMED THAT THERE IS NO EXPECTED REVISION SURGERY NEEDED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505492 RADIOLUCENT DRIVE DRILL BIT INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR