BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3011926 · Received March 19, 2013

    Report

    Report Number
    2530088-2013-00340
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 24, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4). THE RETURNED AIMING ARM WAS MANUFACTURED IN APRIL 2006 AND IS 7 YEARS OLD. THE RETURNED INSERTION HANDLE WAS MANUFACTURED IN MARCH 2003 AND IS OVER 10 YEARS OLD. DURING THIS EVALUATION, THE RETURNED INSERTION HANDLE AND AIMING ARM FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED A CANNULATED CONNECTING SCREW, TROCHANTERIC FIXATION NAIL, 100MM HELICAL BLADE, BLADE GUIDE SLEEVE, BUTTRESS COMPRESSSION NUT, HELICAL BLADE INSERTER, HELICAL BLADE COUPLING SCREW AND BALL HEX SCREWDRIVER. THE CONSTRUCT ASSEMBLED AND THE HELICAL BLADE ALIGNED AND PASSED THROUGH THE TFN AS INTENDED. THE COMPLAINT CONDITION OF THE HELICAL BLADE MISSING THE NAIL HOLE COULD NOT BE REPLICATED DURING THIS EVALUATION. THE RETURNED INSERTION HANDLE AND AIMING ARM WERE ASSEMBLED WITH KNOWN GOOD PARTS OF THE CONSTRUCT AND ENABLED AN ADEQUATE CONSTRUCT DURING THIS EVALUATION. THE HELICAL BLADE ALIGNED AND PASSED THROUGH THE TFN AS INTENDED. THE DESIGN IS ADEQUATE FOR IT'S INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013, WHILE SURGEON WAS INSERTING THE HELICAL BLADE, THE BLADE HUNG UP ON THE LATERAL EDGE OF THE TFN NAIL. SURGEON BELIEVES THE INSERTION HANDLE AND AIMING ARM PREVENTED THE NAIL AND BLADE FROM LINING UP CORRECTLY. SURGEON PULLED THE NAIL OUT, CHECKED ALL CONNECTIONS, RE-DRILLED ORIGINAL HOLE TO ENSURE GUIDE WIRE WOULD CENTER, AND THEN REINSERTED THE HELICAL BLADE. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THERE WAS NO HARM TO PATIENT. THIS IS 3 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113166 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4537011

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR