BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3091398 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02103
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 5, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE INVESTIGATION HAS SHOWN THAT THE BLUE HANDLE CAME INDEED OFF SO THAT THE CHUCK COULD NOT BE LOOSENED ANYMORE. THERE IS NO VISIBLE DAMAGE ON THE INSTRUMENT AS SUCH WHICH COULD SUGGEST EXTENSIVE HANDLING. WE CAN ONLY SUPPOSE THAT THE THREADED PART WAS NOT SUFFICIENT GLUED AND GOT LOOSE OVER TIME BUT THIS IS ONLY AN ASSUMPTION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, A TITANIUM ELASTIC NAIL (TEN) INSERTER FELL APART. THIS OCCURRED WHILE INSERTING A NAIL. IT WAS REPORTED THAT THE INSERTER SHATTERED INTO MULTIPLE PIECES. NO PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194892 INSERTER F/TEN LXH SYNTHES GMBH 7978769

    Patients

    Seq Age Sex Outcome Treatment
    1