BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSI SPECIALTY SURGICAL

    MDR report key: 1892946 · Received November 1, 2010

    Report

    Report Number
    MW5018035
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 1, 2010
    Manufacturer
    SSI SPECIALTY SURGICAL
    Product Code
    HTC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING A WIRE CUTTER TO REMOVE A MEDULLARY ROD FROM THE FEMUR. A POST-OP XRAY REVEALED A SMALL FRAGMENT OF SOMETHING IN THE SOFT TISSUE OF THE CHILD'S OPERATIVE LEG. THE PT WAS RETURNED TO SURGERY AND A C-ARM WAS USED TO IDENTIFY THE FB. THE SURGEON REMOVED A SMALL PIECE OF THE WIRE CUTTER TIP FROM THE SOFT TISSUE OF THE CHILD'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSI SPECIALTY SURGICAL WIRE CUTTING PLIERS HTC SSI SPECIALTY SURGICAL 32-102

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Disability