BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3011933 · Received March 19, 2013

    Report

    Report Number
    1719045-2013-00627
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THIS IS 2 OF 5 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013 DURING THE DRILLING FOR THE DISTAL LOCKING SCREW FOR A SHORT TFN NAIL THROUGH THE DOUBLE GREEN DRILL PROTECTION SLEEVE, UTILIZING THE 130 DEGREE AIMING ARM, THE 4.0MM CALIBRATED DRILL BIT WAS HITTING THE POSTERIOR ASPECT OF THE NAIL AND SKIVING OFF POSTERIOR TO THE NAIL. THE SURGEON MADE SURE THE INSERTION HANDLE AND CONNECTING SCREW WERE TIGHT TO THE PROXIMAL END OF THE NAIL, AND THE AIMING ARM WAS SECURED TO THE INSERTION HANDLE. THE DRILL BIT COULD NOT DRILL CENTER TO THE NAIL HOLE. SURGEON HAD TO FREE HAND THE DRILLING WITHOUT THE SLEEVE AND AIMING ARM, IN ORDER TO LOCATE THE CENTER OF THE DISTAL NAIL SCREW HOLE, AND INSERT THE DISTAL 5.0MM SCREW. THIS IS 2 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114889 CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS FZX SYNTHES MONUMENT IS10347

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR