BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED CROSS CUT BUR, SHORT

    MDR report key: 2904160 · Received January 3, 2013

    Report

    Report Number
    9616696-2013-90003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    HBE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADES AND PACKAGING SUBJECT TO THIS INVESTIGATION WERE NOT RETURNED FOR EVAL. THE MANUFACTURING HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. IF THE BLADES AND PACKAGING ARE RETURNED. AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT RECEIPT OF THE DEVICES AT THE HOSPITAL, IT WAS NOTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF TEN DEVICES. IT WAS ALSO REPORTED THAT THESE DEVICES WERE NOT USED ON A PT AND THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE OUTER SHIPPING BOX, WHICH CONTAINED THE DEVICES, WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477 TAPERED CROSS CUT BUR, SHORT HBE STRYKER IRELAND LTD 12212017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK