BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3880237 · Received June 18, 2014

    Report

    Report Number
    1030489-2014-02777
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL REVIEW IDENTIFIED APPROXIMATELY ~8MM OF THE PROXIMAL TIP BROKEN OFF AND NOT RETURNED FOR ANALYSIS. OPTICAL INSPECTION OF THE SHAFT IDENTIFIED AXIAL GALLING IN MULTIPLE LOCATIONS NEAR THE FRACTURE SURFACE, CONSISTENT WITH OFF-AXIS TRAJECTORY WHILE UNDER POWER. HELICAL FRACTURE SURFACE MORPHOLOGY SUGGESTS TORSIONAL OVERLOAD. DIMENSIONAL INSPECTION CONFIRMS SHAFT DIAMETER CONFORMS TO PRINT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED AT L5 ON THE RIGHT SIDE. APPROXIMATELY 7-8 MM BROKE OFF. THE FRAGMENT WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THE BONE SCREW WAS PLACED USING ANOTHER GUIDEWIRE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357710 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT GUIDE, SURGICAL, INSTRUMENT FZX MEDTRONIC SOFAMOR DANEK USA, INC NA SW13E063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BONE SCREW