BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2070716 · Received April 18, 2011

    Report

    Report Number
    2520274-2011-00116
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION CAN BE DRAWN. NO PRODUCT IS BEING RETURNED FOR INVESTIGATION. DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED WITHOUT A PART AND LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED: DURING A TFN PROCEDURE, THE HELICAL BLADE WOULD NOT GO THROUGH THE NAIL. THE SURGEON MODIFIED THE IMPLANT BY CUTTING A SMALL PIECE FROM THE TIP OF THE BLADE WITH BOLT CUTTERS. THE SURGEON COMPLETED THE PROCEDURE WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI HELICAL BLADE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI NAIL