BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE

    MDR report key: 2170026 · Received July 13, 2011

    Report

    Report Number
    8030965-2011-00502
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM WALDENBURG INDICATES A CLINIC IN SPAIN REPORTED: PT STATUS POST PFNA 130 DEGREES NAIL IMPLANTATION RETURNED TO SURGEON. AN X-RAY IN (B)(6), 2010 SHOWED THE NAIL BROKE. SURGEON WAS REMOVING THE HARDWARE AND EXPERIENCED PROBLEMS REMOVING THE BLADE WITH THE EXTRACTOR. SURGEON DID REMOVE ALL HARDWARE. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE BLADE KTW SYNTHES GMBH 2624541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention