BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 280

    MDR report key: 22360740 · Received June 30, 2025

    Report

    Report Number
    8030965-2025-06634
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 10, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982291110
    PMA / PMN Number
    K233696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: 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

    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: B5, D10 (CONCOMITANT). 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 # 04.233.428S. LOT # 34499P3. MANUFACTURING SITE: DEPUY SYNTHES PRODUCTS, INC. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 23 SEP 2024. EXPIRATION DATE: 01 SEP 2029. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR SUPRACONDYLAR FEMORAL FRACTURE WITH THE NAIL. SINCE THE MEDULLARY CAVITY WAS WIDE, THE NAIL WAS INSERTED MANUALLY WITHOUT REAMING, BUT ONLY AT THE END, THE NAIL WAS INSERTED TO THE INDICATED POSITION BY LIGHTLY HAMMERING SEVERAL TIMES. AFTER THAT, THE DISTAL PART WAS FIXED WITH FOUR SCREWS, AND WHEN THE PROXIMAL PART WAS CHECKED FROM THE FRONT BY FLUOROSCOPY, A CRACK-LIKE LINE WAS SEEN FROM THE TIP OF THE NAIL, BUT IT WAS NOT POSSIBLE TO BE CERTAIN, SO THE SURGERY WAS CONTINUED. WHEN THE CIRCULAR PART OF THE AP HOLE WAS DRILLED AND THE SCREWS WERE INSERTED, THE CORTICAL BONE IN FRONT WAS RAISED, AND A FRACTURE WAS CONFIRMED. THEREFORE, ALL THE NAILS AND SCREWS WERE REMOVED, REPLACED WITH A 320MM NAIL, AND FOUR DISTAL SCREWS AND TWO PROXIMAL SCREWS WERE INSERTED AGAIN, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SURGEON AND THE SALES REP DISCUSSED THE CAUSES OF THIS INCIDENT, INCLUDING A MISMATCH BETWEEN THE FEMORAL LORDOSIS AND THE NAIL SHAPE, WHICH PUT STRESS ON THE ANTERIOR CORTICAL BONE (INCLUDING HAMMERING), THE TIP WAS INSERTED IN A FORWARD DIRECTION DUE TO THE EFFECT OF ENTERING TOO RIGIDLY INTO THE MEDULLARY CAVITY, THE BONE QUALITY OF THE (B)(6) YEAR-OLD ELDERLY PERSON IS FRAGILE, AND IT IS POSSIBLE THAT THE FRACTURE WAS PRESENT FROM THE BEGINNING. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ALLEGATIONS AGAINST THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755217 RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 280 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 34499P3 10886982291110

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Unknown UNK - SCREWS: NAIL DISTAL LOCKING.| UNK - SCREWS: NAIL DISTAL LOCKING.| UNK - SCREWS: NAIL DISTAL LOCKING.| UNK - SCREWS: NAIL DISTAL LOCKING.| UNK - SCREWS: NAIL PROXIMAL LOCKING.| UNK - SCREWS: NAIL PROXIMAL LOCKING.