BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMHS ASIAN INSTRUMEN

    MDR report key: 2102299 · Received May 25, 2011

    Report

    Report Number
    1020279-2011-00171
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE RETAINING ROD FRACTURED BY DUCTILE OVERLOAD DUE TO TORSION APPLIED TO THE ROD. AN OVERLOAD FRACTURE CAN OCCUR IF THE MECHANICAL LOADS APPLIED TO THE ROD EXCEED THE STRENGTH OF THE MATERIAL. NO MATERIAL DEVIATIONS IN THE RETAINING ROD WERE FOUND DURING THIS INVESTIGATION. IT WAS UNKNOWN IF THE FRACTURE WAS INITIATED IN A PRIOR SURGERY. IT WAS ALSO CONCLUDED THAT THE SET SCREW DRIVER FAILED DUE TO DISASSEMBLY DURING USE. THE DOWEL PIN AND SPRING, WHICH HELD THE DRIVER ASSEMBLY TOGETHER, WERE NOT RETURNED. THEREFORE, NO ANALYSIS ON THE DOWEL PIN WAS POSSIBLE TO DETERMINE THE CAUSE FOR THE PIN TO HAVE DISASSOCIATED FROM THE DRIVER ASSEMBLY. NO MATERIAL DEVIATIONS WERE FOUND IN THE PARTS THAT WERE RETURNED (UNIVERSAL SWIVEL SHAFT & UNIVERSAL SET SCREW DRIVER SOCKET) DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING USE CAUSING SURGERY TIME TO BE EXTENDED 30-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMHS ASIAN INSTRUMEN SET SCREW DRIVER LXH SMITH & NEPHEW, INC. 496160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization (B)(4)