BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6285839 · Received January 30, 2017

    Report

    Report Number
    0008010177-2017-00022
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    January 6, 2017
    Report Date
    July 18, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. IN THE RELATED TI 4690/17 IT WAS STATED: ONE BONE SCREW, CROSS-PIN, 2.0XXXMM BROKEN DURING SURGERY, WAS RETURNED IN ORDER TO DETERMINE 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 - (B)(4). 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. NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    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 A SCREW (PART# 50-20412) HEAD BROKE OFF WHILE USING THE TROCAR. THE SCREW END IS STILL IN THE PATIENT. PART# 62-00414 X 1 THE SPRING POPPED OUT OF CHEEK RETRACTOR. HOWEVER, THE CASE WAS FINISHED WITH NO SURGICAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW (PART# 50-20412) HEAD BROKE OFF WHILE USING THE TROCAR. THE SCREW END IS STILL IN THE PATIENT. PART# 62-00414 X 1 THE SPRING POPPED OUT OF CHEEK RETRACTOR. HOWEVER, THE CASE WAS FINISHED WITH NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71353 BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1