BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRODESIS NAIL, LEFT 13 X 700MM

    MDR report key: 1564841 · Received December 1, 2009

    Report

    Report Number
    9610622-2009-00420
    Event Type
    Malfunction
    Date Received
    December 1, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 4, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE CASE WAS AN EXCHANGE-NAILING FOR A NON-UNION. PT HAD A 10MMX700MM T2 ARTHRODESIS NAIL IN. IT WAS REMOVED AND DR. DAHL REAMED UP 2 SIZES IN ORDER TO PUT IN OUR 13X700MM ARTHRODESIS NAIL. WHEN THAT IMPLANT WAS OPENED, IT HAD RIPPED THROUGH BOTH SETS OF PLASTIC STERILE PACKAGING. BOTH THE INNER AND OUTER BOXES WERE INTACT, BUT THERE WAS NO "END-CAP" OVER THE SHARP DRIVING END OF NAIL END, IT RIPPED THROUGH STERILE PACKAGING AND WAS NOT STERILE. SURGEON HAD TO REAM DEEPER IN PT'S TIBIA AND PUT IN A 13X740MM NAIL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHRODESIS NAIL, LEFT 13 X 700MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K133245

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other