BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PLATE, MP, 4 HOLE, MEDIUM BAR

    MDR report key: 3502492 · Received December 5, 2013

    Report

    Report Number
    0008010177-2013-00293
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. THE MACROSCOPIC AND MICROSCOPIC INVESTIGATIONS SHOW THAT - ONE BONE PLATE, MP, 4 HOLE, MEDIUM BAR - THE PLATE WAS HEAVILY DAMAGED WITH MATERIAL BULGING BY MEDICAL INSTRUMENTS DURING THE BENDING / ADAPTATION TO THE ANATOMY OF THE PATIENT AND FINALLY BROKE BY EXCEEDING THE MATERIALS STRENGTH IN FORCED RUPTURE MODE. THE FRACTURE ORIGIN COULD BE LOCATED IN SURFACE DAMAGES CAUSED BY MEDICAL INSTRUMENTS. MOREOVER THE PLATE SHOWS IN PLACES HEAVY DAMAGES WITH MATERIAL BULGING CAUSED BY MEDICAL INSTRUMENTS. THE DAMAGES LEAD TO A MASSIVE LOCAL STRAIN HARDENING / EMBRITTLEMENT OF THE MATERIAL AND COULD HAVE FINALLY RESULTED UNDER FUNCTIONAL LOAD ALSO IN A BREAKAGE OF THE PLATE. IN THE IFU IS DOCUMENTED UNDER: GENERAL WARNINGS AND PRECAUTIONS THAT ¿ ¿SCRATCHING OR DAMAGE TO THE COMPONENT CAN SIGNIFICANTLY REDUCE THE STRENGTH AND FATIGUE RESISTANCE OF THE PRODUCT¿. THE INVESTIGATION WITH SEM SHOWS ON THE FRACTURED SURFACES THE HONEY COMB STRUCTURE OF A FORCED RUPTURE AS WELL AS SECONDARY CRACKS. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR (B)(6) WAS USING BENDERS TO BEND IN THE PLATE AND THE PLATE SNAPPED IN HALF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. (B)(6) WAS USING BENDERS TO BEND IN THE PLATE AND THE PLATE SNAPPED IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633005 BONE PLATE, MP, 4 HOLE, MEDIUM BAR IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1