BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE

    MDR report key: 4102738 · Received September 19, 2014

    Report

    Report Number
    0008010177-2014-00264
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, A METALLURGICAL EXAMINATION COULD NOT BE PERFORMED. PREVIOUS INVESTIGATIONS SHOW THAT IN MOST OF THE CASES THE REPORTED FAILURE MODE COULD BE ATTRIBUTED TO INSUFFICIENT/INAPPROPRIATE CLEANING AND/OR STERILIZATION PROCEDURES, LEADING TO THE APPEARANCE OF RUST AND CORROSION. AS A RESULT THE AFFECTED COMPONENTS WERE WEAKENED OVER TIME EVENTUALLY LEADING TO BREAKAGES. BASED ON STATISTICAL EVALUATION THERE IS NO INDICATION FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. IF THE PRODUCT WILL BE RETURNED AT A LATER DATE A THOROUGH INVESTIGATION WILL BE PERFORMED, THE COMPLAINT WILL BE REOPENED AND THE RESULT REVISED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE RECEIVED CALL THIS MORNING FROM (B)(6) THAT IN-SITU CUTTER WAS DAMAGED. UPON INSPECTION OF UNIT THE SCREW AT THE CUTTING JUNCTION IS FRACTURED/CRACKED. NO ADVERSE CONSEQUENCES OR ASSOCIATED PROCEDURE.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE RECEIVED CALL THIS MORNING FROM SPD THAT IN-SITU CUTTER WAS DAMAGED. UPON INSPECTION OF UNIT THE SCREW AT THE CUTTING JUNCTION IS FRACTURED/CRACKED. NO ADVERSE CONSEQUENCES OR ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584277 IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE INSTRUMENT LXH STRYKER LEIBINGER-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1