BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL POINTER

    MDR report key: 3882315 · Received June 18, 2014

    Report

    Report Number
    0001811755-2014-02195
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 NOT YET RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF OF THE SMALL POINTER DURING REPROCESSING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF OF THE SMALL POINTER DURING REPROCESSING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358866 SMALL POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1