BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X16MM, (5/PACKAGE)

    MDR report key: 7541620 · Received May 24, 2018

    Report

    Report Number
    0008010177-2018-00043
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    April 26, 2018
    Report Date
    September 14, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. IN THE RELATED TI 5103/18, IT WAS STATED THAT: "ONE BONE SCREW, CROSS-PIN, 2.0XXXMM BROKEN DURING SURGERY, WAS RETURNED IN ORDER TO DE-TERMINE THE ROOT CAUSE OF THE FAILURE. THE RETURNED SCREW WAS EXAMINED REGARDING ITS DIMENSIONS, CHEMICAL COMPOSITION (EDX ANALYSIS) AS WELL AS BY LIGHT AND SCANNING ELECTRON MICROSCOPY. THE (MEASURABLE) DIMENSIONS ARE IN ACCORDANCE WITH THE SPECIFICATION. THE CHEMICAL COMPOSITION CONFORMS TO THE SPECIFICATION - TIAL6V4 (TI GRADE 5). THE INVESTIGATION SHOWS THAT THE SCREW BROKE AS A RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUP-TURE 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.¿ FURTHER INFORMATION WAS REQUESTED IN ORDER TO GAIN MORE INSIGHT IN THE REPORTED EVENT. THE LOT NUMBER OF THE SCREW COULD NOT BE PROVIDED. HOWEVER, THE SALES REPRESENTATIVE HAS RESPONDED TO THE FOLLOW-UP INQUIRY THAT THE SCREW IN QUESTION COULD BE A 50-20416 OR A 50-20414. DUE TO THIS INFORMATION, PRODUCT DETAILS (E.G. CATALOG NUMBER) WERE UPDATED IN ECHS. FURTHER, THE SURGEON HAS USED THE FOLLOWING DEVICES WITH THE SCREW IN QUESTION: BLADE 62-20130 WHICH IS INTENDED TO BE USED FOR 2.0/2.3MM SCREWS. DRILL 60-16526 IS MEANT TO BE USED FOR SCREW LENGTH OF UP TO 20MM. THEREFORE, BOTH THE BLADE AND THE DRILL ARE APPROPRIATE TO BE USED WITH THE SCREW IN QUESTION. NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A SCREW HEAD HAD FRACTURED INTRAOPERTIVELY. THERE WAS NO MEDICAL INTERVENTION, DELAY IN SURGERY, OR ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    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 BY A COMPANY REPRESENTATIVE THAT A SCREW HEAD HAD FRACTURED INTRAOPERTIVELY. THERE WAS NO MEDICAL INTERVENTION, DELAY IN SURGERY, OR ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385957 BONE SCREWS, CROSS-PIN, DIAM.2.0X16MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1