BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS PRECISION NEURO, 3.0MM

    MDR report key: 2924982 · Received January 22, 2013

    Report

    Report Number
    0001811755-2013-00036
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR AND ATTACHMENT SUBJECT TO THIS INVESTIGATION WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BUR WAS BROKEN ALONG THE SHANK. THE RETURNED BUR WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MIS SURGICAL PROCEDURE ON THE BACK, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT A BACK-UP DEVICE WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29957 MIS PRECISION NEURO, 3.0MM DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), LOT: 12116