BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 4094021 · Received September 16, 2014

    Report

    Report Number
    3003875359-2014-10272
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE RETURNED DEVICE SHOWS THAT THE IMPLANT GRIPPER COMPONENT IS NOT PUSHED BY THE INSTRUMENT TO IS RESTING POSITION SO THAT THE IMPLANT CAN BE INSERTED AS INTENDED. HOWEVER WITH SOME ADDITIONAL FORCE THE GRIPPER CAN BE PUSHED TO THE CORRECT LOCATION. PRODUCT DEVELOPMENT DOES NOT SEE A SYSTEMIC DESIGN FAULT REGARDING THIS ISSUE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS NO LONGER WORKING ADEQUATELY, THE TENSIONING TRIGGER WILL NO LONGER WORK. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572747 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 8572594

    Patients

    Seq Age Sex Outcome Treatment
    1