BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3192620 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04134
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 3, 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE PRESENT INSERTER WAS BROKEN OFF DUE TO A MECHANICAL OVERLOAD. FURTHERMORE IT WAS CONDUCTED, THAT THIS INSTRUMENT WAS MANUFACTURED IN APRIL 2004 TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HEAD OF THE TITANIUM ELASTIC NAIL (TEN) INSERTER INSTRUMENT BROKE OFF DURING USE ON (B)(6) 2013. THE INTRAOPERATIVE INSERTION OF THE TEN WAS NOT POSSIBLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294567 INSERTER F/TEN LXH SYNTHES GMBH 8001688

    Patients

    Seq Age Sex Outcome Treatment
    1