BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 2820995 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02956
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A SURGEON IN (B)(6) REPORTED: DURING A PROCEDURE SURGEON WAS INSERTING A ZIP FIX AS USUAL AND THE NEEDLE SNAPPED. QUESTED WHETHER THERE WAS SIDE TO SIDE MOVEMENT WITH THE NEEDLE AT THE JUNCTION WHERE THE NEEDLE AND IMPLANT MEET. SURGEON REPLIED POSSIBLY. IT WAS REINFORCED THAT THE NEEDLE ISN''T DESIGNED FOR SIDE TO SIDE FORCES, MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK STERNAL ZIPFIX W/NEEDLE JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1