BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL/PELVIC TRACKER

    MDR report key: 4223075 · Received November 4, 2014

    Report

    Report Number
    0001811755-2014-03938
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT THAT ONE OF THE LEDS WITH THE BLACK IR FILTER FELL OUT OF THE UNIT WAS CONFIRMED DURING VISUAL INSPECTION. IT WAS OBSERVED THAT THE COVER OF THE LARGE LED LENS WAS BROKEN OFF. BASED ON A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE, SCRATCHING OR DAMAGING THE LEDS IN ANY WAY MAY CAUSE OR CONTRIBUTE TO THE BROKEN LED COVER. THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LEDS WITH THE IR FILTER FELL OUT OF THE TIBIAL/PELVIC TRACKER DURING PROCESSING PRIOR TO THE START OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. A BACKUP DEVICE WAS USED, AND THE SUBSEQUENT PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LEDS WITH THE IR FILTER FELL OUT OF THE TIBIAL/PELVIC TRACKER DURING PROCESSING PRIOR TO THE START OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. A BACKUP DEVICE WAS USED, AND THE SUBSEQUENT PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705697 TIBIAL/PELVIC TRACKER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1