BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA3 380X110MM

    MDR report key: 3181203 · Received June 21, 2013

    Report

    Report Number
    0009610622-2013-00356
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTS OR IN THE MATERIAL. THE RETURNED LAG SCREWDRIVER WAS DOCUMENTED AS MEETING SPECIFICATIONS PRIOR TO DISTRIBUTION. THUS, DEVIATIONS IN MATERIAL AND MANUFACTURING CAN BE EXCLUDED. MARKS FROM MATERIAL DISPLACEMENT AT THE VERY TIP OF THE PEGS AND THE BEND ON THE PEGS THEMSELVES INDICATE THAT THE SCREWDRIVER WAS OPERATED UNDER HIGH FORCE IN CCW / UNTIGHTENING DIRECTION, WHILST THE PEGS WERE NOT ENTIRELY ENGAGED IN THE SLOTS OF THE LAG SCREW. EVALUATION OF ANY DAMAGE CHARACTERISTICS SUGGESTS THAT THE ITEM WAS NOT USED AS INTENDED. IT CANNOT BE EXCLUDED THAT THE ITEM WAS DAMAGED DURING PREVIOUS SURGERIES, BUT THE DAMAGE WOULD THEN HAVE BEEN DETECTED DURING INSPECTION PRIOR TO SURGERY. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RELATED TO IMPROPER USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE SALES REP, THAT THE SCREWDRIVER DOESN¿T FIT VERY WELL WITH THE COLLUM SCREW DURING THE GAMMA3 PROCEDURE. SALES REP REPORTED THAT ANOTHER TRAY WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE SALES REP, THAT THE SCREWDRIVER DOESN¿T FIT VERY WELL WITH THE COLLUM SCREW DURING THE GAMMA3 PROCEDURE. SALES REP REPORTED THAT ANOTHER TRAY WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281863 LAG SCREWDRIVER GAMMA3 380X110MM INSTRUMENT LXH STRYKER TRAUMA KIEL K396526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other