BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 2132296 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02087
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED WHICH REVEALED EXCESSIVE CORROSION, BURNT CONTACT PINS WITHIN THE MOTOR ASSEMBLY, AND DAMAGED BEARINGS. THE DEVICE ALSO HEATED UP DURING THE EVALUATION. THE MOTOR ASSEMBLY, ROTOR ASSEMBLY, AND BEARINGS WERE REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE DRILL CONTINUED TO OPERATE WHEN THE TRIGGER WAS NOT ACTIVATED. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A DELAY. NO PATIENT 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 UNIVERSAL DRILL HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK