BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM HEADLESS COMPRESSION SCREW-LONG THREAD 17MM

    MDR report key: 22339645 · Received June 26, 2025

    Report

    Report Number
    8030965-2025-06459
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    10886982059123
    PMA / PMN Number
    K161616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 REVIEW PART # 02.226.317 LOT # 9945527 MANUFACTURING SITE: WERK GRENCHEN RELEASE TO WAREHOUSE DATE: 12 MAY 2016 SUPPLIER: N/A EXPIRATION DATE: N/A A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE PREVIOUSLY REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THERE WAS NO FAILURE OF THE DEVICE. NO FURTHER FOLLOW-UPS WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ABOUT TWO TO THREE MONTHS, A DEFECT OCCURRED IN THE CPX4 TAB; A LEAK OCCURRED IN THE FASTENING TAB. IT WAS NECESSARY TO SURGICALLY REPLACE THE EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529783 2.4MM HEADLESS COMPRESSION SCREW-LONG THREAD 17MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 9945527 10886982059123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown