BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 8668209 · Received June 4, 2019

    Report

    Report Number
    8030965-2019-64895
    Event Type
    Injury
    Date Received
    June 4, 2019
    Report Date
    May 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819418424
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. THE SURGEON HAD TO KEEP PULLING THE TRIGGER OUT OF ITS STUCK POSITION EACH TIME. THERE WAS A SURGICAL DELAY OF 30 MINUTES. DEVICE HISTORY LOT: PART # 03.501.080, LOT # 9790420. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 31.MAR.2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. INVESTIGATION SUMMARY: WE HAVE FORWARDED THE RECEIVED INFORMATION TO SUSTAINING ENGINEERING FOR INVESTIGATION, FIND THE STATEMENT BELOW: THE FUNCTIONAL TESTS PERFORMED ON THE RETURNED DEVICE, AFTER ITS LUBRICATION ACCORDING TO THE SURGICAL TECHNIQUE IT SHOWS THAT THE DEVICE IS FULLY FUNCTIONAL AS PER ITS DESIGN INTEND. THEREFORE, THE ¿NOT LUBRICATED¿ CONDITION OF THE RETURNED DEVICE IS IDENTIFIED AS THE ROOT CAUSE REGARDING THE INTRA OPERATIVE INSTRUMENT MAIL FUNCTION. NO DESIGN RELATED ISSUE WAS IDENTIFIED ON THE RETURNED DEVICE. THIS COMPLAINT IS THEREFORE CLOSED BY THE PRODUCT DEVELOPMENT AS INVALID. 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 REPORTS AN EVENT IN (B)(6). IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING SURGERY ON (B)(6) 2019, THE SPRING SYSTEM OF THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS NOT WORKING PROPERLY. THE TRIGGER GOT STUCK EVERY TIME THE SURGEON TRIED TO PULL IT TO APPLY TENSION TO THE STERNAL ZIPFIX IMPLANT. THE SPRING SYSTEM WAS SUSPECTED TO BE THE PROBLEM. THE SURGEON HAD TO KEEP PULLING THE TRIGGER OUT OF ITS STUCK POSITION EACH TIME. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH STEEL WIRE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: UNKNOWN STERNAL ZIPFIX (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460419 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 9790420 07611819418424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention