BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER

    MDR report key: 1021952 · Received March 28, 2008

    Report

    Report Number
    1719045-2008-00027
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT WAS NOT IMPLANTED. ANOTHER OF THE SAME PART NUMBER WAS IMPLANTED SUCCESSFULLY. SUBJECT DEVICE HAS BEEN RECEIVED, AND IS CURRENTLY IN THE EVAL PROCESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN IM RODDING OF THE FEMUR FOR A PROXIMAL FEMORAL FRACTURE, THE SURGEON WAS UNABLE TO DISENGAGE THE INSERTION HANDLE AND THE CANNULATED CONNECTING SCREW, FROM THE CANNULATED TROCHANTERIC FIXATION NAIL. THE NAIL WAS REMOVED AND ANOTHER NAIL OF THE SAME PART NUMBER WAS USED TO COMPLETE THE PROCEDURE. THE OCCURRENCE PROLONGED THE PROCEDURE AN ADD'L 30 MINUTES ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER TROCHANTERIC FIXATION NAILS JDS SYNTHES MONUMENT NA 5618028

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR INSERTION HANDLE AND CANNULATED CONNECTING SCREW