BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT MEDIUM ELITE ATTACHMENT

    MDR report key: 1972750 · Received January 21, 2011

    Report

    Report Number
    1811755-2011-00206
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RETURNED TO THE MFR FOR AN UNRELATED ISSUE AND UPON EVAL, AN OVERHEATING CONDITION WAS FOUND. INTERNAL COMPONENTS WERE EVALUATED AND A DAMAGED BEARING WAS DISCOVERED. DAMAGED BEARINGS CAN RESULT IN HEAT BEING GENERATED, DUE TO EXCESSIVE FRICTION BETWEEN ROTATING COMPONENTS. THE DRILL ATTACHMENT COULD NOT BE REPAIRED, AND THEREFORE, WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT MEDIUM ELITE ATTACHMENT DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK