BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)

    MDR report key: 5765199 · Received July 1, 2016

    Report

    Report Number
    0008010177-2016-00145
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 24, 2016
    Report Date
    February 23, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THE SCREW HEAD WAS RETURNED FOR INVESTIGATION AND THE REPORTED EVENT COULD BE CONFIRMED. THE INVESTIGATION SHOWS THAT THE BONE SCREW, CROSS-PIN, DIAM. 2.0 X XX MM BROKE AS A RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUPTURE MODE DURING THE INSERTION. THE CHEMICAL COMPOSITION CONFORMS TO THE SPECIFICATION - TIAL6V4 (TI GRADE 5). THE FRACTURE SURFACE SHOWS THE TYPICAL FLOW STRUCTURES OF A DUCTILE TORSIONAL BREAKAGE. THE ROOT CAUSE OF THE FAILURE COULD HAVE BEEN A TOO SMALL DIAMETER OR A TOO LOW DEEPNESS OF THE PILOT HOLE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT WAS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE REPORTED THAT A SCREW ((B)(4)) WAS BEING INSERTED INTO PREDRILLED HOLED WITH THE CORRECT SCREWDRIVER BLADE ((B)(4) TWIST DRILL & (B)(4)), AND THE SCREW HEAD SNAPPED OFF WHEN THE SURGEON WAS COMPLETING THE DRIVER PART (SCREW WAS ALL THE WAY DOWN).

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE REPORTED THAT A SCREW (5020412) WAS BEING INSERTED INTO PREDRILLED HOLED WITH THE CORRECT SCREWDRIVER BLADE (9216135 TWIST DRILL & 6220130), AND THE SCREW HEAD SNAPPED OFF WHEN THE SURGEON WAS COMPLETING THE DRIVER PART (SCREW WAS ALL THE WAY DOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419549 BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1