BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 2896532 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04113
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL, DAMAGED SOCKETS WERE FOUND, WHICH WERE IDENTIFIED AS A PROBABLE CAUSE OF THE DEVICE OPERATING WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR FACILITY, THE DEVICE RAN WITHOUT USER ACTIVATION WHEN THE CABLE WAS FLEXED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MFR FACILITY, THERE WAS NO PT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK