BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 2925952 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00223
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE ZIPFIX IMPLANT WAS RECEIVED IN THREE PIECES. THE LOCKING MECHANISM IS COMPLETELY BROKEN APART AND PARTIALLY DEFORMED. THE RELEVANT DIMENSIONS OF THE BROKEN ZIPFIX CAN NOT BE VERIFIED ANYMORE DUE TO THE ABOVE MENTIONED DAMAGES. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE DEVICE WENT TO PRODUCT DEVELOPMENT FOR EVALUATION: FUNCTIONAL INSPECTION; WE INSERTED THE CUT END OF THE RETURNED DEVICE INTO THE LOCKING HEAD, IN ITS CORRECT ORIENTATION AND THE DEVICE LOCKED. THIS INDICATES THAT THE LOCKING FUNCTION IS AS PER THE DESIGN INTENDED. PDC COULD REPLICATE THE SAME OR SIMILAR SITUATION WHEN THE DEVICE WAS INSERTED INCORRECTLY INTO THE LOCKING HEAD BY ROTATING THE DEVICE 180 DEGREES. IN THE CLINICAL APPLICATION THIS WOULD MEAN THAT THE DEVICE BODY TEETH WOULD NOT FACE THE STERNUM BONE. IN THIS SITUATION THE USER MAY APPLY SOME TENSION TO THE DEVICE WHILE PULLING THE APPLICATION INSTRUMENT TRIGGER. IF THE USER THEN CUTS THE DEVICE; THE DEVICE WILL SNAPS BACK OPEN AS PER THE COMPLAINT DESCRIPTION. THE SAMPLES USED BY PDC TO REPLICATE THIS SITUATION DID ALSO NOT SHOW ANY DEFORMATIONS TO THE LOCKING FEATURE AND, OR LOCKING HEAD. THE DEVICES COULD BE LOCKED AGAIN IN ITS CORRECT ORIENTATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A QUANTITY OF TWO WAS REPORTED FOR THE ZIPFIX IMPLANT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A CABG PROCEDURE ON (B)(4) 2013, THE LOCKING MECHANISM ON THE ZIPFIX FAILED. ACCORDING TO THE THORACIC COORDINATOR, THE ZIPFIX MADE A POPPING SOUND AND THEN THE LOCKING MECHANISM SHOT ACROSS THE ROOM AND THEY WERE UNABLE TO FIND IT. THEY TRIED ANOTHER ZIPFIX AND IT ALSO BROKE AND THEY COULDN'T FIND THAT ONE EITHER. A NEW BOX OF ZIPFIX WAS AVAILABLE FOR USE AND THE THIRD DEVICE WORKED FINE. THE FIRST TWO DEVICES CAME FROM THE SAME 5-PACK. THE SURGERY WAS PROLONGED 1 - 2 MINUTES. IT WAS REPORTED ONE OF THE DEVICES WAS TAKEN OUT OF THE SHARPS CONTAINER BUT NOT THE OTHER ONE. THEREFORE, ONLY ONE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29039 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK STERNAL ZIPFIX WITH NEEDLE JDQ SYNTHES GMBH 7966439

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR