BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA 10X315 MM

    MDR report key: 2629296 · Received June 22, 2012

    Report

    Report Number
    9610622-2012-00277
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 11, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1896-5060S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X60 MM LOT# K176272; 1896-5050S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM LOT# K197909; 1896-5045S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM LOT# K208701; 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM LOT# K208710; 1823-0010S END CAP T2 TIBIA 8, +10MM LOT# K235535.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2 TIBIA EXTRACTION OPERATION WAS PERFORMED. THE PT WAS IN AN ACCIDENT WHICH CAUSED THE NAIL TO BEND. THE SCREWS HAD BENT TOO. SURGEON TRIED TO EXTRACT THE NAIL, BUT BENT NAIL WAS NOT EXTRACTED EASILY. SURGEON OPENED THE WOUND GREATLY, EXPOSED NAIL, AND SHAVED THE BROKEN NAIL BY DIAMOND BAR. WHILE SHAVING NAIL SPARS WERE INTENSE (IT BLEW UP 1 M OR MORE) AND PT WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL, STANDARD T2 TIBIA 10X315 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K177317

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention