BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 1705362 · Received May 27, 2010

    Report

    Report Number
    9616696-2010-00245
    Event Type
    Injury
    Date Received
    May 27, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER DETAILS ARE NOT AVAILABLE TO ASSIST FURTHER INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFORATOR BIT (PART. #5100-060-001) NEVER STOPPED AND TORE THROUGH THE PATIENT'S DURA DURING A CRANIAL PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other