BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE

    MDR report key: 22080823 · Received May 23, 2025

    Report

    Report Number
    8030965-2025-05188
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819649965
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: H3, H6: PART 04.037.044S, LOT 9457P80: RELEASE TO WAREHOUSE DATE: JANUARY 29, 2024. EXPIRY DATE: JANUARY 01, 2034. MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SURFACE OF THE DEVICE SHOWS DAMAGE CONSISTENT WITH REMOVAL AN IMPLANTATION SURGICAL PROCEDURE. ADDITIONALLY, THE LOCKING PRONG ASSEMBLY WAS DAMAGED BROKEN IN SEVERAL FRAGMENTS. NOT ALL FRAGMENTS WERE RETURNED FOR ANALYSIS. AREA OF BREAKAGE WAS ALSO OBSERVED DEFORMED. THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. THE OBSERVED CONDITION OF THE DEVICE CAN BE CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. HOWEVER, WITH AVAILABLE INFORMATION, THE COMPLETE POTENTIAL CAUSE CANNOT BE DETERMINED. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GRUB SCREW BROKE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025 BUT DID NOT EXPERIENCE ANY ADVERSE EVENTS RELATED TO THE BROKEN SCREW. THE PATIENT IS CURRENTLY DOING WELL; THE PATIENT GOT A HIP PROSTHESIS. AFTER PRODUCT WAS RETURNED, IT WAS NOTED THAT TWO LOCKING SCREWS WERE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221082 10MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 9457P80 07611819649965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention