BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 11674943 · Received April 15, 2021

    Report

    Report Number
    8030965-2021-02966
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    March 20, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    UDI-DI
    07611819418400
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY: PICTURE REVIEW: NARRATIVE. ONE OF FOUR ZIPFIX BAND IS CRACKED AND COULD BE VERIFIED FROM PROVIDED PICTURE. THEREFORE, THE COMPLAINT IS RATED AS CONFIRMED. THE REVIEW OF THE PICTURE DOES NOT ALLOW TO ANY DETERMINATION OF ANY ROOT CAUSE. PRODUCT WAS NOT RETURNED THEREFORE NO FURTHER INVESTIGATION POSSIBLE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT. PART: 08.501.001.01S LOT: L864964 MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: JUNE 05, 2018. EXPIRY DATE: MAY 01, 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN ZIPFIX PASSES THROUGH THE STERNUM, THE NOTCH WHERE NEEDLE AND PEEK ARE CONNECTED BREAKS. THERE ARE SIMILAR SITUATIONS WHEN USING 5 OF EACH CONSECUTIVELY. THE FIRST ONE IS COMPLETELY BROKEN, AND THE SECOND TO 4TH HAVE CRACKS. THERE WAS NO FRAGMENT GENERATED. THERE WAS NO DELAY REPORTED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573793 STERNAL ZIPFIX WITH NEEDLE STERILE CERCLAGE FIXATION JDQ SYNTHES GMBH L864964 07611819418400

    Patients

    Seq Age Sex Outcome Treatment
    1