BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED HELICAL BLADE 90MM - STERILE

    MDR report key: 21797225 · Received April 8, 2025

    Report

    Report Number
    8030965-2025-03297
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 14, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    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 04.038.390S, LOT 27683P1: MANUFACTURING SITE: WERK SELZACH LOGISTIK. MANUFACTURING DATE: JULY 11, 2024. EXPIRATION DATE: JULY 01, 2034. SUPPLIER: (B)(4) MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE TFNA HELICAL BLADE APPEARS TO HAVE MIGRATED FROM ITS ORIGINAL POSITION. 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 WOULD 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 CUT-OUT OF TFNA HELICAL BLADE OCCURRED POST OPERATIVELY (PATIENT WAS ALLOWED FOR FULL WEIGHT BEARING AFTER PRIMARY SURGERY). NAIL AND BLADE ARE NOT AVAILABLE FOR ANALYSIS, THEY HAVE BEEN DISPOSED OF BY THE CUSTOMER. HOWEVER, THE IMPLANTS WERE ALL INTACT, NO FRACTURE, IT WAS A PURE CUT-THROUGH OF THE HELIX BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707312 TFNA FENESTRATED HELICAL BLADE 90MM - STERILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 27683P1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention