BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 WAY PECTUS BAR BENDER

    MDR report key: 1651469 · Received April 6, 2010

    Report

    Report Number
    1032347-2010-00036
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 29, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE BENDING THE PECTUS BAR, THE UPPER BOLT OF THE BENDER CAME OFF AND HIT THE SURGEON IN THE STOMACH, AND THEN IT HIT THE CEILING, THE WALL AND THE FLOOR. THE INSTRUMENT FELL OUT OF THE SURGEON'S HANDS. THE SURGERY WAS SUCCESSFUL, AND THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE SURGEON HAD A HEMATOMA. THE SURGEON WENT TO A DOCTOR FOR EXAMINATION, THE DOCTOR ISSUED HIM A SICK NOTE FOR FOUR WEEKS, BUT THE SURGEON DID NOT WANT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 WAY PECTUS BAR BENDER PECTUS BAR BENDER HXW BIOMET MICROFIXATION

    Patients

    Seq Age Sex Outcome Treatment
    1