BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 1911043 · Received November 24, 2010

    Report

    Report Number
    9616696-2010-00344
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    July 13, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MFR FOR EVAL, IT WAS DISCARDED. INVESTIGATION RESULTS INDICATE THAT THIS SURGEON DRILLED IN THE TEMPORAL REGION OF THE SKULL. THE IFU FOR THIS PRODUCT STATES "CAUTION SHOULD BE TAKEN TO AVOID USE IN SKULLS/SKULL AREAS THAT HAVE THIN BONE (E.G. TEMPORAL AND SUBOCCIPITAL AREAS). FAILURE TO COMPLY MAY RESULT IN SERIOUS PATIENT INJURY OR DEATH". HOWEVER AS THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, THE EVENT CANNOT BE CONFIRMED. LOT NUMBER INFO WAS NOT PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE FOR A CHRONIC SUB DURAL HEMATOMA, THE DURA WAS TORN. IT WAS ALSO REPORTED THAT AS A RESULT OF THIS EVENT, THERE WAS POTENTIAL INJURY TO THE BRIAN IN THE FORM OF A CEREBELLAR CONTUSION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other