BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3226116 · Received July 15, 2013

    Report

    Report Number
    1030489-2013-03017
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    FZK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW IDENTIFIED BEND IN APPROXIMATELY THE MIDDLE OF THE GUIDEWIRE, WITH APPROXIMATELY ~35MM OF THE PROXIMAL TIP BROKEN OFF AND NOT RETURNED FOR ANALYSIS. OPTICAL INSPECTION OF THE SHAFT IDENTIFIED AXIAL GALLING IN MULTIPLE LOCATIONS NEAR THE PROXIMAL TIP AND ADJACENT TO THE FRACTURE SURFACE, CONSISTENT WITH OFF-AXIS TRAJECTORY WHILE UNDER POWER. DIMENSIONAL INSPECTION CONFIRMS SHAFT DIAMETER CONFORMS TO PRINT SPECIFICATION. REVIEW OF LHR DOCUMENTATION CONFIRMS CONFORMANCE TO CHEMICAL COMPOSITION PER MSD-MS-119 TYPE F. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OFF-AXIS TRAJECTORY OF THE INSTRUMENT WHILE UNDER POWER, RESULTING IN AXIAL GALLING OF THE SHAFT UNTIL FAILURE OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL SPINAL SURGERY TO TREAT A RETROODONTOID PSEUDOTUMOR. IT WAS REPORTED THAT DURING INSERTION OF THE GUIDEWIRE THROUGH THE GUIDE AND A TROCAR USING A POWER TOOL, THE GUIDEWIRE FRACTURED IN THE BONE BEFORE IT PERFORATED C2 ARTHROSIS. THE TIP WAS LODGED IN THE C2 BONE. A DIAMOND BUR WAS USED TO WIDEN THE INSERTION POINT TO REACH THE FRAGMENT. AFTER THE FRAGMENT WAS DRILLED, THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT USING PLIERS. THE SURGERY WAS CONTINUED USING A NEW GUIDEWIRE WITHOUT ANY FURTHER INCIDENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325490 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT CHAIR, SURGICAL, NON-ELECTRICAL FZK MEDTRONIC SOFAMOR DANEK USA, INC NA SW12M145

    Patients

    Seq Age Sex Outcome Treatment
    1