BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3183648 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03649
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR VISUAL INSPECTION AND THE EVENT WAS CONFIRMED. THE ARTICLE IN QUESTION WAS SUBJECTED TO A DETAILED INVESTIGATION IN OUR PRODUCT DEVELOPMENT CENTER. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE ITEM WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THE CAUSE OF THE DEVICE FAILURE IS USER RELATED AND IS THEREFORE A NON VALID COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIP FIX OPENED UP DURING SURGERY. AFTER STERNAL CLOSURE WITH ZIPFIX AND WIRE AT THE MANUBRIUM, THE SECOND ZIPFIX OPENED UP FROM BELOW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284447 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 7795441

    Patients

    Seq Age Sex Outcome Treatment
    1