BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFN-ADVANCED POLYMER INLAY STERILE

    MDR report key: 23020129 · Received September 10, 2025

    Report

    Report Number
    8030965-2025-09174
    Event Type
    Injury
    Date Received
    September 10, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982347572
    PMA / PMN Number
    K233696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE X-RAY INVESTIGATION REVEALED NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE, SINCE THE POLYMER INLAY IS INTO THE NAIL AND COUND TO BE OBSERVED IN THE EVIDENCE PROVIDED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE RFN-ADVANCED POLYMER INLAY WOULD HAVE NOT CONTRIBUTED TO THE REPORTED ADVERSE EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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 APPROXIMATELY 1 YEAR AGO, THE PATIENT UNDERWENT AN ORIF SURGERY WITH RFNA IMPLANTS AND A SLP FOR A FEMORAL CONDYLAR FRACTURE AT ANOTHER HOSPITAL. AFTER THE SURGERY, A REVISION SURGERY WAS SCHEDULED DUE TO NON-UNION. THE IMPLANTS WERE REMOVED, REPLACED WITH A COMPETITOR'S PRODUCTS, AND RE-FIXATION WAS DONE SUCCESSFULLY ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518957 RFN-ADVANCED POLYMER INLAY STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 10886982347572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention