BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PEDICLE FEELER

    MDR report key: 3983032 · Received August 6, 2014

    Report

    Report Number
    0001811755-2014-02798
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT THAT THE TIP WAS BROKEN OFF WAS CONFIRMED THROUGH THE VISUAL INSPECTION. DURING THE DEVICE EVALUATION WE WERE UNABLE TO DETERMINE WHAT CAUSED THE BROKEN TIP. IT IS POSSIBLE ROUGH OR IMPROPER HANDLING LED TO THE BROKEN TIP. THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP SNAPPED OFF THE THORACIC PEDICLE FEELER DURING A SPINAL FUSION PROCEDURE. NOTHING FELL INTO THE SURGICAL SITE. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP SNAPPED OFF THE THORACIC PEDICLE FEELER DURING A SPINAL FUSION PROCEDURE. NOTHING FELL INTO THE SURGICAL SITE. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461057 THORACIC PEDICLE FEELER INSTRUMENT, ULTRASONIC SURGICAL HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1