BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD/NAIL FIXATION

    MDR report key: 3110584 · Received May 14, 2013

    Report

    Report Number
    2520274-2013-02491
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO CATALOG NUMBER OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    WHILE DRILLING THROUGH THE NAIL FOR A SUBTROCHANTERIC FEMUR FRACTURE, THE DRILL BIT BROKE OFF AND BECAME IMBEDDED IN THE FEMUR OF THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE. THE SURGEON IMMEDIATELY DETERMINED THAT IT WOULD BE SAFER TO LEAVE THE BIT IMBEDDED IN THE PATIENT RATHER THAN ATTEMPT TO REMOVE IT. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212454 ROD/NAIL FIXATION HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR