BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125

    MDR report key: 2835673 · Received November 7, 2012

    Report

    Report Number
    9610622-2012-00499
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 3060-0105S LAG SCREW, TI GAMMA3 10.5X105MM, LOT# K272794; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40MM, LOT# K281076; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM, LOT# K982498.

    Description of Event or Problem · 1

    THE NURSE REPORTED TO OUR SALES REP THAT A PATIENT CAME IN WITH PAIN AND IT WAS OBSERVED THAT THE NAIL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K292840

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R