BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS

    MDR report key: 1021928 · Received March 28, 2008

    Report

    Report Number
    2530088-2008-00009
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    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 ADDITIONAL 30 MINS ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS CANNULATED CONNECTING SCREWS/TFN JDS SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR CANNULATED TROCHANTERIC FIXATION NAIL| INSERTION HANDLE