BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FLUTED BUR, LONG

    MDR report key: 1900187 · Received October 22, 2010

    Report

    Report Number
    9616696-2010-00312
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. THE DEVICE IS CURRENTLY IN TRANSIT. 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 VIA THE AUSTRALIAN DISTRIBUTION SITE THAT THE PACKAGING OF THE BUR WAS DAMAGED. IT WAS ALSO REPORTED THAT THE BURR WAS NOT USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND FLUTED BUR, LONG DRILLS, BURS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 10012017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK