BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK

    MDR report key: 21949858 · Received May 2, 2025

    Report

    Report Number
    8030965-2025-04430
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 2, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    UDI-DI
    07611819618053
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PREVIOUSLY REPORTED EVENT UNDER MRN 8030965-2025-04430 AND 8030965-2025-04431 ARE NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THERE WAS NO FAILURE OF THE DEVICE. NO FURTHER FOLLOW-UPS WILL BE SENT UNDER MRN 8030965-2025-04430 AND 8030965-2025-04431.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZIPFIX BAND OPENED AFTER BEING TIGHTENED BY THE SURGEON. THIS BAND WAS USED. TWO OTHER BANDS FROM SAME BATCH WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657083 STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK CERCLAGE, FIXATION JDQ SYNTHES GMBH 8764P24 07611819618053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown