BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5535807 · Received March 30, 2016

    Report

    Report Number
    0008010177-2016-00058
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 10, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED; THE SCREW IS BROKEN. THE INVESTIGATION SHOWS 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 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.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT A BONE SCREW (PART # 50-20412) SHREDDED, DURING SURGERY, AFTER GETTING 3/4 OF THE WAY IN. AT WHICH POINT, THE BONE SCREW SNAPPED OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND A PIECE OF THE SCREW WILL BE SENT BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT A BONE SCREW (PART # 50-20412) SHREDDED, DURING SURGERY, AFTER GETTING 3/4 OF THE WAY IN. AT WHICH POINT, THE BONE SCREW SNAPPED OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND A PIECE OF THE SCREW WILL BE SENT BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192075 BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1