BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 3940507 · Received July 17, 2014

    Report

    Report Number
    3003875359-2014-10205
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE RETURNED FIRST GENERATION INSTRUMENT SHOWS MARKS OF LONG TIME USE. THE FUNCTION OF TENSIONING AND CUTTING SEAMS GIVEN OF THE DEVICE, BUT ONE SCREW IS LOOSE. DURING THE INVESTIGATION IT WAS FOUND THAT ONE SCREW OF THE HOUSING HALF¿S WHICH THE BEARING IS ALSO FOR THE TRIGGER IS LOOSE. THE COMPLAINT IS CLOSED BY PRODUCT DEVELOPMENT AS VALID. THE LOOSENING OF THE ¿SCREW¿ COMPONENT HAS BEEN ADDRESSED IN (B)(4) AND WAS COMPLETED IN 13.08.2012 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

    (B)(4): A MANUFACTURING EVALUATION WAS COMPLETED: TWO SCREWS ON THE INSTRUMENT HOUSING IN THE AREA OF THE OPERATING LEVER ARE VISIBLE LOOSE. DUE TO PRESSING OF THE OPERATING LEVER, THE SCREWS ROTATE AND MAY LOOSEN FROM THE INSTRUMENT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT HAS SINCE BEEN REVISED. THE ISSUE CANNOT OCCUR WITH NEWER VERSIONS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 AS THE SET WAS CHECKED, IT WAS NOTED THAT THE UPPER SCREW, NEAR THE CUTTING PART OF THE DEVICE, WAS UNSCREWED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418849 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 7591576

    Patients

    Seq Age Sex Outcome Treatment
    1