BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3073110 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10999
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    THE SALES CONSULTANT WAS NOT PRESENT FOR THIS SURGERY. THE SURGEON REPORTED TO THE SC: CABG PROCEDURE. 1 ZIP FIX : AS THE SURGEON WAS APPLYING THE ZIP FIX, AFTER HE CUT THE EXCESS OFF OF THE IMPLANT, THE IMPLANT DISCONNECTED AT THE CONNECTION POINT. THIS FAILURE OCCURRED IN THE MIDDLE OF THE STERNUM AND THE SURGEON DID NOT USE ANOTHER ZIP FIX TO REPLACE THE ONE THAT HAD DISCONNECTED. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174666 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1