BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND BUR

    MDR report key: 1881912 · Received October 6, 2010

    Report

    Report Number
    9616696-2010-00298
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION WAS RETURNED FOR EVAL TO THE MFG SITE. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING WAS DAMAGED AND THE BUR WAS BENT. THE MFG HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PACKAGING AND THE BUR WAS DAMAGED RESULTING IN A BREACH TO THE STERILE BARRIER. IT WAS ALSO REPORTED THAT THE BUR WAS NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS FURTHER REPORTED ANOTHER BUR WAS READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND BUR DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER IRELAND LTD. 07199017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK