BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVTEK CARTRIDGE

    MDR report key: 2012194 · Received March 3, 2011

    Report

    Report Number
    MW5019678
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORTHOPAEDIC SURGEON WAS USING A POWER DRILL DURING A PROCEDURE. WHILE DRILLING THE ATTACHED DRILL BIT BROKE OFF AND REMAINED LODGED IN THE BONE. MINI C-ARM XRAY WAS USED TO CONFIRM ALL OF THE MISSING DRILL BIT WAS IN THE OPERATIVE BONE. SURGEON CONFIRMED ALL OF IT WAS IMBEDDED IN THE BONE, AND HE CONCLUDED THAT TRYING TO REMOVE IT WOULD CAUSE MORE DAMAGE THAN LEAVING IT IN PLACE. THE BROKEN BIT WAS LEFT IN THE BONE. PT SUSTAINED MINIMAL EXTENDED ANESTHESIA TIME DURING THE CONFIRMATION PERIOD. NO OTHER ADVERSE AFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVTEK CARTRIDGE DRILL BIT HTW BIOMET SPORTS MEDICINE 906750 341090 906750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization