BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM / TI CANN FRN / GT 420MM / LEFT - STERILE

    MDR report key: 23377477 · Received October 24, 2025

    Report

    Report Number
    8030965-2025-10657
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    October 2, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982271921
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: H3 H6 INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO AND X-RAY INVESTIGATION REVEALED THAT THE FEM RECON NAIL GT Ø12 LE L 420 TAN WAS FRACTURED INTO TWO PARTS AT THE POSTERIOR AREA OF THE FEMUR, NEAR THE INTERSECTION WITH THE BLADE. NO OTHER ISSUES WERE OBSERVED. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. 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 CONFIRMED AS THE OBSERVED CONDITION OF THE FEM RECON NAIL GT Ø12 LE L 420 TAN WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. 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 REVIEW (DHR): PART: 04.033.273S. LOT: 2L16469. MANUFACTURING SITE: WERK BETTLACH. SUPPLIER: NA. RELEASE TO WAREHOUSE DATE: 08 NOV 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SUBTROCH NON-UNION THAT RESULTED IN HARDWARE FAILURE. A DEPUY SYNTHES FRN NAIL THAT WAS IMPLANTED ON (B)(6) 2024 TO TREAT A SUBTROCH FRACTURE EXPERIENCED A FAILURE AT A NON-UNION SITE AND WAS REVISED WITH A DEPUY SYNTHES TFNA IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611985 12MM / TI CANN FRN / GT 420MM / LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 2L16469 10886982271921

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention