BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/RIGHT-STERILE

    MDR report key: 23729111 · Received December 5, 2025

    Report

    Report Number
    8030965-2025-12214
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    May 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819427341
    PMA / PMN Number
    K141796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: E1 FACILITY NAME. 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: A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT: 16899P8, ARTICLE: 04.12.550S-15, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ON 11/24/2025: DHR REVIEW FOR THE FOLLOWING DEVICE CONDUCTED: PRODUCT CODE # 04.120.550S-15. LOT # 16899P8. MANUFACTURING DATE: 05/06/2024. EXPIRY DATE: 05/01/2034. NO NON-CONFORMANCE / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. (B)(4). 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FEMORAL OSTEOTOMY AND INTERNAL FIXATION DUE TO VARUS DEFORMITY OF THE KNEE AND DEVELOPED WOUND REDNESS AND FEVER 2 WEEKS AFTER SURGERY, WHICH WAS DIAGNOSED AS SOFT TISSUE INFECTION. THE PATIENT WAS IN STABLE CONDITION AFTER EXPANSION VSD IMPLANTATION AND ANTI-INFECTION TREATMENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2884466 TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/RIGHT-STERILE PLATE, FIXATION, BONE HRS SYNTHES GMBH 16899P8 07611819427341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention