BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGR FEM NAIL ADV - RFN-ADV Ø10 L 240

    MDR report key: 24068019 · Received January 14, 2026

    Report

    Report Number
    8030965-2026-00487
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 26, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07612334210685
    PMA / PMN Number
    K233696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: 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 LOT: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 26-MAY-2022. EXPIRATION DATE: UNKNOWN. PART NUMBER: 04.233.024S, 10MM/RFN/240MM/5 ANG/POLY INLAY/STER. LOT NUMBER: 728P372 (STERILE). LOT QUANTITY: 6. COMPONENT PART(S) REVIEWED: COMPONENT PART REVIEW FOR PART NUMBER 04.233.124.2Y / LOT NUMBER 592P251 NEEDS TO BE ASSIGNED TO THE BRANDYWINE DHR REVIEW TEAM. PART NUMBER: 21131, TIALV*RI13.00. LOT NUMBER: 648P319. QTY: (B)(4). INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFIED TEST REPORT SUPPLIED BY PERRYMAN COMPANY. DATED 06-DEC-2021 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 10-FEB-2022 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH BATCH NUMBER 728P372. NO NONCONFORMITIES OR MANUFACTURING IRREGULARITIES HAVE IDENTIFIED RELATED TO THE COMPLAINT CONDITION. 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) 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. 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 THE PATIENT HAD THE INITIAL IMPLANT PROCEDURE ON (B)(6) 2025 FOR FEMORAL SHAFT WITH THE NAIL THAT WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR A BROKEN NAIL AT THE FOURTH HOLE FROM THE PROXIMAL END. THE NAIL WAS REMOVED AND REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132082 RETROGR FEM NAIL ADV - RFN-ADV Ø10 L 240 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 728P372 07612334210685

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female