BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA ATO INSTRUMENT

    MDR report key: 932833 · Received April 5, 2007

    Report

    Report Number
    2184052-2007-00006
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Date of Event
    March 12, 2007
    Report Date
    March 12, 2007
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE DEVICE CONFIRMS INSTRUMENT MANUFACTURED TO CORRECT MATERIAL AND HEAT TREAT SPECIFICATIONS WHICH AGREES WITH THE DHR. THE INSTRUMENT WAS RETURNED BUT THE BROKEN PIN WAS NOT.

    Description of Event or Problem · 1

    DURING SURGERY, THE ALIGNMENT STAND PIN BROKE OFF THE INSTRUMENT WHILE THE SURGEON WAS SEATING THE INSTRUMENT ON THE CERVICAL PLATE. ACCORDING TO THE FIELD REP THE SURGEON USED A SUCTION DEVICE TO REMOVE THE BROKEN TIP FROM THE SURGICAL FIELD; HOWEVER, THE SUCTION DEVICE WAS NOT INSPECTED TO CONFIRM THE PRESENCE OF THE PIN. X-RAYS WERE TAKEN AND DID NOT REVEAL THE BROKEN PIN IN THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH THE INSTRUMENT. NO ADVERSE EVENT OCCURRED DURING SURGERY. THIS REPORT IS BEING MADE BECAUSE THERE IS NO CONCRETE EVIDENCE THAT THE BROKEN PIN WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA ATO INSTRUMENT VARIABLE ATO DRILL TUBE HXY ZIMMER SPINE, INC. 07.00344.701 P061089

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other