BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE)

    MDR report key: 3830544 · Received May 23, 2014

    Report

    Report Number
    0008010177-2014-00132
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. THE INVESTIGATION RESULTS SHOWED THAT THE SCREW 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 ROOT CAUSE OF THE FAILURE WAS THAT AFTER THE SCREW CONTACTED THE PLATE, IT WAS FORCIBLY FURTHER TURNED. NO INDICATIONS WERE FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    DURING SURGERY SURGEON WAS USING A 4 HOLE CURVED PLATE WITH THE CORRECT SCREW AND THE CORRECT DRILL BIT. THE SCREW WAS ABOUT 80% TO 90% IN AND THE SCREW HEAD BROKE OFF. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    DURING SURGERY SURGEON WAS USING A 4 HOLE CURVED PLATE WITH THE CORRECT SCREW AND THE CORRECT DRILL BIT. THE SCREW WAS ABOUT 80% TO 90% IN AND THE SCREW HEAD BROKE OFF. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308334 BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1