BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM TI ELASTIC NAIL 440MM

    MDR report key: 3072216 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-02071
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTY
    PMA / PMN Number
    K971783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO THE SALES CONSULTANT OF AN EVENT THAT OCCURRED ON (B)(6) 2013. REPORTEDLY DURING AN IM NAILING HUMERUS FRACTURE PROCEDURE WITH TI ELASTIC NAILS, THE 2.5MM TI ELASTIC NAIL KINKED AND BROKE UPON INSERTION. THE SURGEON INSERTED ANOTHER NAIL AND COMPLETED THE PROCEDURE. THE BROKEN NAIL WAS NOT IMPLANTED IN THE PATIENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173622 2.5MM TI ELASTIC NAIL 440MM HTY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR