BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 2904086 · Received January 9, 2013

    Report

    Report Number
    8030965-2013-00080
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE IMPLANT IS IN ONE PIECE AND JUST APPEARS AS THOUGH THE LOCKING MECHANISM FAILED. WE SEE TWO CLEARLY OVER-DEFORMED TEETH. THERE SHOULD BE THREE LESS DEFORMED TEETH PRESENT. WE SEE SOME DEFORMATIONS TO THE LOCKING HEAD WHICH SHOULD NOT HAVE HAD AN INFLUENCE ON THE LOCKING PERFORMANCE OF THE DEVICE. IT IS ASSUMED THE MARKS WERE CREATED DURING THE REMOVAL OF THE DEVICE. THE LOCKING FEATURE WAS DEFORMED DURING THE APPLICATION INSERTION WHICH PREVENTED THE THIRD TOOTH OF THE LOCKING FEATURE FROM ENGAGING. BASED OF THE FINDINGS THE DEVICE FAILURE IS THE RESULT OF THE FEWER TEETH ENGAGED IN THE LOCKING AS PER DESIGN INTENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH ZIPFIX ON (B)(6) 2012. PATIENT PRESENTED TO THE SURGEON WITH A LUMP IN THE CHEST. AFTER EXAMINATION, THE SURGEON NOTED THAT THE LAST ZIPFIX IMPLANT DOWN IN THE XYPHOID REGION HAD BROKEN OR CAME APART POST-OPERATIVELY. THE SURGEON REMOVED THE ZIPFIX IMPLANT ON (B)(6) 2012 UNDER LOCAL ANESTHETIC. REPORTEDLY THERE WAS NO INFECTION PRESENT OR ANY TISSUE DAMAGE TO THE PATIENT. THE STERNUM HAD HEALED AND THE OTHER FOUR ZIPFIX IMPLANTS REMAINS IMPLANTED IN THE PATIENT AND IS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12259 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK STERNAL ZIPFIX W/NEEDLE PEEK JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention