BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 6348309 · Received February 21, 2017

    Report

    Report Number
    1719045-2017-10131
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    January 25, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. ITEM 08.501.001.01S- LOT # 9870231. MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4). MANUFACTURING DATE: 19.APR.2016 EXPIRY DATE: 19.APR.2019 NO NON-CONFORMANCES 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE RETURNED IMPLANT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. ALTHOUGH THE BREAKAGE CANNOT BE REPLICATED, THE RETURNED IMPLANT EXHIBITED DAMAGE CONSISTENT WITH RESISTING HIGH FORCE PRIOR TO THE EVENTUAL BREAKAGE. THE SEGMENT THAT WOULD CONTAIN THE NEEDLE WAS NOT RETURNED BUT THE EDGES OF THE PORTION ADJACENT TO THE MISSING FRAGMENT WERE FLATTENED AND MALFORMED BEFORE THE SUDDEN BREAK. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE STERNAL ZIPFIX SYSTEM IS INDICATED FOR PRIMARY OR SECONDARY CLOSURE/REPAIR OF THE STERNUM FOLLOWING STERNOTOMY OR FRACTURE OF THE STERNUM TO STABILIZE THE STERNUM AND PROMOTE FUSION. PER TECHNIQUE GUIDE FOR THE STERNAL ZIPFIX SYSTEM, FIVE (5) ZIPFIX IMPLANTS ARE RECOMMENDED FOR A FULL MIDLINE STERNOTOMY WHEN NO OTHER PLATES ARE USED FOR FIXATION. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: 08.501.001.01S. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE SPECIFIC DETAILS REGARDING THE APPLICATION OF FORCE AND METHOD OF USE ARE UNKNOWN; THEREFORE, NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE IDENTIFIED. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. (B)(4). 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. (B)(6) (B)(4). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORDS REVIEW WILL BE REQUESTED. (B)(4). 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 THAT THE PATIENT HAD A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE DONE ON (B)(6) 2016. DURING INITIAL PROCEDURE THE SURGEON USED THE STERNAL ZIPFIX SYSTEM. IT WAS OBSERVED AT SOME UNKNOWN POINT POST-OPERATIVELY THAT THE ZIPFIX TIE IMPLANT BROKE. ON (B)(6) 2016 SURGEON BROUGHT THE PATIENT BACK TO THE OPERATING ROOM AND REMOVED THE BROKEN TIE IMPLANT. UPON INSPECTION OF THE IMPLANT, IT WAS REPORTED THAT THE BROKEN TIE HAD SHEERING AT THE HEAD OF THE IMPLANT. DUE TO THE FACT THAT THE PATIENT¿S STERNUM HAD HEALED, NO ADDITIONAL IMPLANT WAS NEEDED. THE IMPLANT WAS EASY REMOVED WITH NO FRAGMENTS GENERATED. THE PATIENT WAS REPORTED IN STABLE CONDITION AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130664 STERNAL ZIPFIX WITH NEEDLE STERILE CERCLAGE FIXATION JDQ SYNTHES SELZACH 9870231

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention