BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 2920221 · Received December 17, 2012

    Report

    Report Number
    1811755-2012-04272
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT THE CONTACT PINS ARE BURNT AND BENT. CORROSION DAMAGE AND VARNISH BUILD-UP WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    THE UNIVERSAL DRILL WAS SENT FOR EVALUATION DUE TO RUNNING ON ITS OWN WITHOUT USER ACTIVATION DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY PROCEDURE DELAY. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK