BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTP SCR TARGETING GUIDERIGHT

    MDR report key: 23111279 · Received September 22, 2025

    Report

    Report Number
    3020584246-2025-00047
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Manufacturer
    SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: ADDED: H4. 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 (DHR): PART # 03.900.395. LOT # 653703. MANUFACTURING SITE: CROSSROADS EXTREMITY SYSTEMS, LLC. SUPPLIER: NA. RELEASE TO WAREHOUSE DATE: 30 APR 2025. EXPIRATION DATE: NA. 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

    PRODUCT COMPLAINT # (B)(4). 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 THE SALES REP WAS EXPERIMENTING WITH THE TRILEAP SET AND NOTICED THE AIMING GUIDE FOR THE MTP WAS VERY DIFFICULT TO ATTACH AND DETACH. IT FELT TIGHT AND NOT PLIABLE TO SQUEEZE TOGETHER TO INSERT OR TO REMOVE. IT WAS UNABLE TO CLICK INTO THE PLATE WITHOUT EXTREME FORCE AND WAS EVEN HARDER TO TAKE OUT THEN AS WELL. THE ISSUE WAS NOTED PREOPERATIVELY AND THE SET HAD NEVER BEEN USED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594436 MTP SCR TARGETING GUIDERIGHT GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 653703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown