BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 7960785 · Received October 12, 2018

    Report

    Report Number
    0008010177-2018-00099
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 16, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K172572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE PRODUCT IS NOT AVAILABLE, AN IMAGE OF THE BROKEN SCREW HAS BEEN PROVIDED IN TRACKWISE (FIG. 1). THEREFORE THE EVENT COULD BE CONFIRMED. MOREOVER, IN A FOLLOW-UP EMAIL, THE SALES REP HAS ALSO PROVIDED THE CATALOG NUMBER OF THE AFFECTED SCREW (56-12903) AND THE USED BLADE (62-12174) DURING THE PROCEDURE. THE SCREWDRIVER BLADE IS INTENDED TO BE USED FOR 1.2/1.7 MM AXS SCREWS, HENCE THE BLADE WAS APPROPRIATE TO BE USED FOR THE AFFECTED SCREW. THE FOLLOWING ARE EXAMPLES OF POSSIBLE ROOT CAUSES ACCORDING TO THE RELATED RISK MANAGEMENT FILE: INSUFFICIENT/TOO HIGH BONE QUALITY. WRONG/ MISSING INFORMATION. IMPLANT/INSTRUMENT MIX-UP. IMPROPER IMPLANT PLACEMENT (E.G. ARCH BAR, SCREW...). LOCKING MECHANISM FIXED TOO EARLY OR NOT PROPERLY FIXED. TOO MUCH/ WRONG FORCES BETWEEN BLADE, SCREW AND BONE (E.G. SCREW HEAD DEFORMATION, SCREW BREAKAGE). WRONG/ MISSING INFORMATION. PLATE BECOMES LOOSE DURING FIXATION - TOO MUCH/ WRONG COMPRESSION/ TORSIONAL/ AXIAL FORCES. IMPROPER BLADE DISENGAGING. COLLISION WITH OTHER IMPLANT OR INSTRUMENT. BASED ON STATISTICAL EVALUATION THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. IF THE DEVICE WILL BE RETURNED, THE INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CASE, THE SCREW BROKE IN HALF. NO DELAYS NOR ADVERSE CONSEQUENCES WERE REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CASE, THE SCREW BROKE IN HALF. NO DELAYS NOR ADVERSE CONSEQUENCES WERE REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799707 UNKNOWN_FRO_PRODUCT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1