BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2033728 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00922
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THERE WAS CORROSION DAMAGE TO THE PRESS PLUG, THE MOTOR AND THE ROTOR. THE MID SPEED MOTOR WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE EVENT. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO DRILL WAS SENT IN FOR REPAIR BECAUSE IT WAS OOZING OIL DURING EQUIPMENT TESTING. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE MICRO DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK