BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3790032 · Received May 5, 2014

    Report

    Report Number
    9612488-2014-10153
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE 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. THERE WERE NO NCRS GENERATED DURING PRODUCTION. 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 PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: TWO DEVICES WERE RETURNED CLOSED AND COULD NOT BE OPENED BY HAND; THEREFORE THE CUT ENDS WERE PUSHED FURTHER THROUGH THE LOCKING HEAD TO INSPECT THE DEFORMATIONS TO THE BODY TEETH ON THE DEVICE. IT WAS FOUND THAT ON ALL FOUR DEVICES THE LAST THREE TEETH WERE SEVERELY DEFORMED. ONE DEVICE LOCKING HEAD WERE OPENED TO INSPECT THE LOCKING FEATURE WITHIN. THE TOOTH ORIGINATION FOUND INDICATES THAT THE DEVICE WAS SUBJECT TO OVERLOADING. THE SAME WAS SEEN ON THE FOURTH DEVICE. ALL RETURNED ZIPFIX DEVICES SHOW SIGNS OF A CORRECT APPLICATION BY THE USER. ALL THE DEVICES SHOW THE SAME DEFORMATION. IT IS DETERMINED THAT THE DEVICES FAIL IS DUE TO AN OVERLOAD SITUATION E.G. AGGRESSIVE COUGHING / PATIENT NON-COMPLIANCE TO RESTRICTION OF MOVEMENTS. NO DESIGN RELATED FAILURE COULD BE IDENTIFIED. 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 PATIENT HAD A CORONARY BYPASS SURGERY AND FOUR OF THE ZIPFIX JUST COULDN'T WITHSTAND THE PRESSURE IN THE BODY AREA OF THE STERNUM. ALL OF THE FOUR ZIPFIX WERE LOOSEN POSTOPERATIVE, THIS INCIDENT HAPPENED DURING EXPIRATION WHEN EXTREME PRESSURE WAS ON STERNUM. AFTER REMOVAL, 3 BANDS WERE TESTED AND ONE BAND LEFT WAS EASY TO SOLVE. THERE WAS AN ADDITIONAL RE-FIXATION WITH THE CERCLAGE WIRE, A RE-OPERATION WAS NECESSARY. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269365 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK CERCLAGE FIXATION JDQ SYNTHES BETTLACH 8423327

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention