BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SABER DRILL

    MDR report key: 2050009 · Received March 14, 2011

    Report

    Report Number
    1811755-2011-00813
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND THE MOTOR ASSEMBLY WAS FOUND TO HAVE WORN BEARINGS. THE MOTOR ASSEMBLY WAS REPLACED AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS PERFORMED. THE HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING, CONDUCTED AT THE USER FACILITY, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT DURING. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE SABER DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK