BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO DIAMOND DRILL, MEDIUM

    MDR report key: 2932422 · Received January 24, 2013

    Report

    Report Number
    9616696-2013-90012
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    September 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE SERIALIZATION STARTING THE 9616696-203-90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS. THE DEVICE PACKAGING OF THE TWO BLADES SUBJECT TO THIS INVESTIGATION, WERE NOT RETURNED FOR EVALUATION. THE MANUFACTURING HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION RESULTS INDICATE THE PACKAGING MATERIAL WAS BRITTLE. THE LABEL FOR THE DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". AN ALTERNATIVE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. IF THE BLADE PACKAGING IS RETURNED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR SURGERY, IT WAS NOTED THAT THE PACKAGING OF TWO BLADES WOULD NOT PEEL OPEN AS SPECIFIED. IT WAS ALSO REPORTED THAT THE BLADE WAS NOT USED ON A PT AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34544 NEURO DIAMOND DRILL, MEDIUM HBE STRYKER IRELAND LTD. 08114017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK