BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3082086 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02033
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION SHOWS THAT ONE OF THREE PRONGS IS INDEED BROKEN OFF. WE ACKNOWLEDGE THAT THIS IS A RATHER DELICATE DESIGN BUT WE SUPPOSE THAT SIMPLY TOO MUCH MECHANICAL FORCE WAS APPLIED AND CAUSED THE BREAKAGE. THE FILE HISTORY RECORDS WERE REVIEWED AND SHOWED CONFORMITY WITH THE MATERIAL AND MANUFACTURING SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED. DURING A TFN PROCEDURE THE TFN INSERTION HANDLE BROKE. THE EXPECTED REASON: SURGEON WAS POSSIBLY TRYING TO INSERT THE NAIL BY HAMMERING ON THE HANDLE EXTENSIONS. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185833 INSERTER F/TEN LXH SYNTHES GMBH 7528425

    Patients

    Seq Age Sex Outcome Treatment
    1