BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3042676 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-01496
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 13, 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. INVESTIGATION COORDINATED BY SYNTHES (B)(4). THE INVESTIGATION HAS SHOWN THAT THE THREAD CAME LOOSE IN THE UPPER REGION. THEREFORE, THE NAIL COULD NOT BE RELEASED ACCORDINGLY. UNFORTUNATELY WE CAN NOT REPRODUCE THE CIRCUMSTANCE OF THE FAILURE AGAIN. WE CAN ONLY ASSUME THAT THE THREAD WAS DAMAGED IN CASE OF MECHANICAL OVERLOADING. IT WAS DETERMINED THAT THE ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS OF THIS TIME. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT ON AN UNKNOWN DATE, A TEN INSERTER DISASSEMBLED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145336 INSERTER F/TEN LXH SYNTHES GMBH 3799879

    Patients

    Seq Age Sex Outcome Treatment
    1