BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE COMP IMPL KIT 18X18X18 2 LEGS

    MDR report key: 21586823 · Received March 12, 2025

    Report

    Report Number
    8030965-2025-02388
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 18, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDR
    UDI-DI
    00810633021682
    PMA / PMN Number
    K150125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 NARRATIVE: H3, H6: PRODUCT CODE: EL-1818S2. LOT: MEL240175. RELEASE TO WAREHOUSE DATE: 20 MAY 2024. EXPIRATION DATE: 01 MAY 2029. SUPPLIER: SYNTHES USA HQ, INC. MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE STAPLES DID NOT PROPERLY DISENGAGE FROM THE INSERTER, CAUSING THEM TO NOT BE ABLE TO BE INSERTED IN THE BONE. A NEW IMPLANT WAS OPENED. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229835 ELITE COMP IMPL KIT 18X18X18 2 LEGS STAPLE, FIXATION, BONE JDR SYNTHES GMBH MEL240175 00810633021682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown