BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQ STERNAL CLOSURE DEVICE

    MDR report key: 1649184 · Received April 1, 2010

    Report

    Report Number
    3007603855-2010-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 26, 2010
    Report Date
    March 31, 2010
    Manufacturer
    KARDIUM INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    KARDIUM REVIEWED PARTS FROM THE SAME MANUFACTURING LOT AND WERE ABLE TO TRACE THE PROBLEM TO A MANUFACTURING ERROR WHEREBY THE DEVICE WAS NOT BUILT TO THE SPECIFICATIONS BY THE CONTRACT MANUFACTURER. SPECIFICALLY, A PART WAS NOT INSTALLED CORRECTLY BY THE CONTRACT MANUFACTURER. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED, WHEREBY THE MANUFACTURING PROCESSES AS WELL AS THE QUALITY CONTROL PROCESSES SUPPORTING THEM HAVE BEEN UPDATED TO PREVENT THIS ISSUE FROM RE-OCCURRING. TO PREVENT A RECURRENCE OF THIS EVENT IN THE FIELD, EXISTING INVENTORY IS BEING INSPECTED AND ANY NON-CONFORMING PRODUCT IS BEING REPLACED. IN ADDITION, SALES REPRESENTATIVES AND DISTRIBUTORS HAVE BEEN NOTIFIED OF THE ISSUE AND PROVIDED WITH INSTRUCTIONS ON HOW TO INSPECT DEVICES FOR THE MANUFACTURING ERROR. THE ERROR IS EASILY NOTICEABLE BY INSPECTION.

    Description of Event or Problem · 1

    A PART OF THE DEVICE WAS PUSHED OUT DURING USE. THE PART FELL ONTO THE PT. THE SURGEON PICKED UP THE PART, REPLACED IT AND THE SURGEON WAS ABLE TO USE THE DEVICE TO TWIST THE WIRE AS DESIGNED. NO PT OR USER WAS HARMED AS A RESULT OF THIS ISSUE. THE CONCERN IS THAT IF THE SURGEON DID NOT NOTICE THE PART, AND IF IT FELL INTO THE WOUND, THERE IS A SMALL CHANCE THAT IT MAY HAVE ENDED UP INSIDE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQ STERNAL CLOSURE DEVICE TWISTER, WIRE LXH KARDIUM INC. TQ01A 20100127

    Patients

    Seq Age Sex Outcome Treatment
    1