BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL POINTER

    MDR report key: 4861352 · Received June 23, 2015

    Report

    Report Number
    0001811755-2015-02274
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 9, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED THROUGH THE VISUAL INSPECTION. DURING THE DEVICE EVALUATION, IT COULD NOT BE DETERMINED WHAT CAUSED THE BROKEN TIP. HANDLING OF THE DEVICE HAS MOST LIKELY CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED, AS IT WAS NOT REPAIRABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE HEALTHCARE FACILITY, THE TIP OF THE SMALL POINTER WAS FOUND TO BE BROKEN OFF. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT, AND THERE WAS NO ASSOCIATED PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE HEALTHCARE FACILITY, THE TIP OF THE SMALL POINTER WAS FOUND TO BE BROKEN OFF. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT, AND THERE WAS NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407106 SMALL POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1