BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 5191740 · Received October 30, 2015

    Report

    Report Number
    9612488-2015-10536
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION EVALUATION: ONE DEVICE WITH LOT NUMBER 9463229 WAS RETURNED FOR THIS COMPLAINT. BASED ON THE FINDINGS DOCUMENTED IN THE NON-MANUFACTURING EVALUATION, IT CAN BE CONCLUDED THAT THE DEVICE¿S NEEDLES WERE INCORRECTLY REMOVED (TWISTED) IN THE AREA OF THE BENDING FEATURE, BY THE USER. THIS ACTION INCREASED THE DEVICE CROSS SECTIONAL AREA. WHILE INSERTING THE ¿DEVICE END¿ INTO THE ¿LOCKING HEAD,¿ THE LOCKING FEATURE TEETH WERE DEFORMED AND THE LOCKING FEATURE ITSELF WAS PUSHED PAST ITS FLEXIBLE STATE. THE DEVICE LOCKING, PER THE DESIGN INTENT, WAS THEREFORE COMPROMISED. IN SUMMARY, THE ROOT CAUSE OF THE DEVICE FAILURES IS USER HANDLING RELATED. DEVICE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE WAS NOT IMPLANTED IN THE PATIENT DUE TO THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    ADDITIONAL NARRATIVE: (B)(4). 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

    IT WAS REPORTED WHILE USING A ZIPFIX DURING A CORONARY ARTERY BYPASS GRAFT SURGERY THAT THE TOOTHED SURFACE OF THE ZIPFIX BAND WOULD NOT ENGAGE ITS LOCKING HEAD AND THEREFORE WOULD NOT TIGHTEN, ALLOWING IT TO SLIP BACK AND FORTH. THERE WAS A FIVE MINUTE DELAY ANOTHER ZIP FIX WAS READILY AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723363 STERNAL ZIPFIX WITH NEEDLE STERILE CERCLAGE FIXATION JDQ SYNTHES BETTLACH 9463229

    Patients

    Seq Age Sex Outcome Treatment
    1