BEUDAMED
    FDA Adverse Event Summary report: N

    BLACK MAX DRILL

    MDR report key: 1070645 · Received June 26, 2008

    Report

    Report Number
    1070645
    Date Received
    June 26, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ANSPACH COMPANIES
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE "BLACK MAX" DRILL WHEN A LOUD "POP" SOUND WAS HEARD. THE PNEUMATIC HOSE ATTACHED TO THE DRILL EXPLODED DUE TO PRESSURE BUILD UP IN THE HOSE. LARGE TEAR RESULTED IN HOSE ON DISTAL END NEAR DRILL CONNECTION. THE PHYSICIAN WAS ESCORTED TO ED FOR EVALUATION OF HEARING AND POSSIBLE EAR DAMAGE. NONE REPORTED. UPON REVIEW OF THE EVENT, IT WAS NOTED THE LEVEL OF OIL IN THE BLACK MAX FOOT PEDAL WAS AT MINIMUM. IT WAS ALSO NOTED THAT THE PNEUMATIC HOSE WAS SLIGHTLY PINCHED UNDER THE FOOT OF A STEP STOOL CAUSING THE PRESSURE IN THE TUBING TO BUILD RESULTING IN THE RUPTURE. THE HOSE IS A DOUBLE-LUMEN HOSE, AND IT IS SPECULATED THAT THE EXHAUST SECTION IS THE ONE WITH THE BUILD UP AND RUPTURE. RECOMMEND DESIGN IMPROVEMENT TO ALERT TO INCREASED PRESSURE SUCH AS ALARM, PRESSURE RELEASE VALUE OR PRESSURE GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACK MAX DRILL DRILL, ORTHOPEDIC, PNEUMATIC HTW ANSPACH COMPANIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES