BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3130010 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02328
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE RETURNED 130 DEGREE AIMING ARM (PART# 357.366, LOT#1884628) WAS MANUFACTURED IN MAY 2008 AND IS APPROXIMATELY 5 YEARS OLD. THE RETURNED BUTTRESS/COMPRESSION NUT (PART#357.371, LOT#5691245) WAS MANUFACTURED IN APRIL 2008 AND IS OVER 5 YEARS OLD. DURING THIS EVALUATION, THE RETURNED AIMING ARM AND BUTTRESS/COMPRESSION NUT FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION OF THE RETURNED DEVICES. THE CONSTRUCT ASSEMBLED AND THE RETURNED DEVICES ALIGNED AND ENGAGED AND DISENGAGED ON EACH ATTEMPT AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAIL SURGERY ON (B)(6) 2013, THE SURGEON WAS ATTACHING THE BUTTRESS/COMPRESSION NUT AND HELICAL BLADE FOR INSERTION INTO THE AIMING ARM. REPORTEDLY THE BUTTRESS/COMPRESSION NUT WOULD NOT LOCK INTO THE AIMING ARM DEVICE. THE SURGEON MANUALLY HELD THE GUIDE SLEEVE AND THE AIMING ARM FOR INSERTION OF THE HELICAL BLADE. IT WAS REPORTED AN ADDITIONAL 5 MINUTES WAS ADDED TO SURGERY DUE TO THIS EVENT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232168 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES GMBH 1884628

    Patients

    Seq Age Sex Outcome Treatment
    1