BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL NAIL 8X300MM

    MDR report key: 2050575 · Received March 15, 2011

    Report

    Report Number
    9610622-2011-00113
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K011529
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, SURGEON WANTED AN 8 X 300MM HUMERAL NAIL. UPON OPENING THE PLASTIC AND THE BOX FOR THE IMPLANT, WE DISCOVERED A HOLE IN THE PLASTIC CONTAINING THE HUMERAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL NAIL 8X300MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K894970

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other