BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 3182888 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03539
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    August 6, 2012
    Report Date
    August 7, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THAT THE NEEDLE BROKE AT THE JUNCTION. THE SURGEON WAS INSERTING THE NEEDLE UNDER THE STERNAL HALF. WHILE PUTTING THE NEEDLE THROUGH THE SECOND STERNAL HALF THE NEEDLE BROKE AT THE JUNCTION WHERE THE NEEDLE ENDS AND THE IMPLANT STARTS. THE BROKEN PARTS WERE RETRIEVED AND DISPOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283047 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1