BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL

    MDR report key: 2905749 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00250
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IMPLANT DATE UNKNOWN. NO PART NUMBER REPORTED, HENCE NO 510K NUMBER CAN BE PROVIDED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE A PATIENT WAS IMPLANTED WITH NAIL, 115MM BLADE, AND TWO LOCKING SCREWS. LATER, X-RAYS REVEALED FRACTURE HAD COLLAPSED, AND BLADE PUNCTURED THROUGH THE FEMORAL HEAD, AND INTO THE JOINT SPACE. THE X-RAYS ALSO REVEALED ONE OF THE LOCKING SCREWS WAS BROKEN AT THE END OF THE NAIL, AND THE OTHER APPEARED TO BE BENT, POSSIBLY BROKEN. ON (B)(6)2012 THE SURGEON OPTED TO ONLY REMOVE THE BLADE AND REPLACE IT WITH A SMALLER 95MM BLADE, TO MINIMIZE INVASIVENESS. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10576 UNK - NAIL NAIL HSB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCREWS, HELICAL BLADE