BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2082071 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01428
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT COULD NOT BE DUPLICATED. HOWEVER, THE FLEX WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE AS DAMAGED FLEX STRIP CAN RESULT IN COMPLETE LOSS OF FUNCTION DUE TO INABILITY FOR HANDPIECE TO TRANSFER USER OR CONSOLE INPUTS INTO USEFUL WORK. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS SENT IN FOR REPAIR BECAUSE IT WAS RUNNING WITHOUT THE TRIGGER BEING ACTIVATED. THE EVENT OCCURRED DURING A PROCEDURE, NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; NO PROCEDURE DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK