BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 1053383 · Received May 29, 2008

    Report

    Report Number
    9616696-2008-00015
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAL. AWAITING FURTHER INFO REGARDING THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE PERFORATOR BIT, IT FAILED TO DISENGAGE AND ONLY STOPPED AFTER DRILLING THROUGH THE DURA. IT WAS REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORATOR BIT LARGE 14/11MM DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER INSTRUMENTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK