BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 1983849 · Received January 11, 2011

    Report

    Report Number
    1811755-2011-00058
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVALUATION, A BEARING WITHIN THE ROTOR ASSEMBLY WAS NOT ROTATING FREELY, WHICH CAN LEAD TO HEAT BEING GENERATED WHEN THE DRILL IS OPERATED. ADDITIONALLY, EXTENSIVE CORROSION WAS DISCOVERED WITHIN THE ROTOR AND MOTOR ASSEMBLIES WHICH CAN LEAD TO EXCESSIVE FRICTION, ALSO RESULTING IN HEAT GENERATION. THE BEARING, ROTOR ASSEMBLY, AND MOTOR ASSEMBLY WERE REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL HEATED UP. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A TWO MINUTE DELAY. NO PT OR 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 U2 DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK