BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6507679 · Received April 20, 2017

    Report

    Report Number
    0008010177-2017-00085
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    April 4, 2017
    Report Date
    June 29, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. IN THE RELATED TI 5039/18, 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 TIAL6V4 (TI GRADE 5). 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. FURTHER INFORMATION WAS REQUESTED SEVERAL TIMES 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 MENTIONED PER MAIL THAT THE SURGEON HAS USED BLADE 62-20130 IN COMBINATION WITH THE AFFECTED SCREW. THE BLADE IS INTENDED TO BE USED FOR 2.0/2.3 MM SCREWS AND THE AFFECTED SCREW HAS A DIAMETER OF 2.0 MM. THEREFORE THE REPORTED BLADE IS APPROPRIATE TO BE USED WITH THE SCREW. ALSO IN THE REPORTED EVENT, IT HAS BEEN MENTIONED THAT A PLATE (92-20506) AND A DRILL (60-16526) WERE USED DURING SURGERY. THESE DEVICES INCLUDING THE USED BLADE AND THE AFFECTED SCREW ARE PART OF THE MANDIBLE FIXATION MODULE. IMPLANTS AND INSTRUMENTS ARE PRODUCED AND DESIGNED TO BE COMPATIBLE FOR USE IN THEIR RESPECTIVE SYSTEM. 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 HAD FRACTURED INTRA OPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION 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 HAD FRACTURED INTRA OPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289173 BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1