BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SCREWS,CROSS-PIN,SELF-DRILLING, DIAM.1.5X4MM

    MDR report key: 4062548 · Received September 5, 2014

    Report

    Report Number
    0008010177-2014-00237
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K031659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED, TWO SCREW HEADS ARE BROKEN OFF AND ONE WING OF THE THIRD SCREW HEAD IS BROKEN. THE INVESTIGATION SHOWS THAT THE TWO SCREWS BROKE AS A RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUPTURE MODE DURING THE INSERTION. THE FRACTURE SURFACE SHOWS THE TYPICAL FLOW STRUCTURES OF A DUCTILE TORSIONAL BREAKAGE. THE HEAD OF THE THIRD SCREW WAS MOST LIKELY HELD WITH PLIERS AND THEREBY A WING OF THE CROSS-PIN WAS PARTIALLY FRACTURED. THE ROOT CAUSE OF THE FAILURE OF THE TWO BROKEN SCREWS COULD HAVE BEEN TIED TO A VERY HARD BONE. THE IFU STATES THAT IN CASES WHERE THE BONE IS KNOWN TO BE DENSE A PILOT HOLE SHOULD BE DRILLED TO FACILITATE INSERTION SHOULD THE SCREWS BE DIFFICULT TO START OR INSERT IN BONE. APPLICATION OF A CONSTANT DOWNWARD/AXIAL FORCE ON THE SCREWDRIVER HANDLE AND EXACT SCREWDRIVER/SCREW ALIGNMENT ARE RECOMMENDED DURING SCREW INSERTION TO ENSURE THAT THE BLADE-TO-SCREW HEAD INTERFACE IS MAINTAINED. THIS INCREASE IN RESISTANCE MIGHT NOT BE CLEARLY PERCEIVED DURING FINAL TIGHTENING. EXTRA CARE SHOULD BE APPLIED IN TIGHTENING THE SCREW TO REDUCE THE RISK OF MECHANICAL DAMAGE TO THE SCREW, SCREWDRIVER OR PLACEMENT SITE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION. BASED ON THE EVALUATION NO INDICATIONS FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS WERE BROKEN; THE SURGEON WAS MADE AWARE WHILE THE SCREWS WERE BEING LOADED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS WERE BROKEN; THE SURGEON WAS MADE AWARE WHILE THE SCREWS WERE BEING LOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545557 NEURO SCREWS,CROSS-PIN,SELF-DRILLING, DIAM.1.5X4MM IMPLANT JEY STRYKER LEIBINGER FREIBURG 1000040034

    Patients

    Seq Age Sex Outcome Treatment
    1