BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7/3.0MM CROSS-PIN BLADE, WITH HEXAGONAL SHAFT END

    MDR report key: 3280831 · Received August 12, 2013

    Report

    Report Number
    0008010177-2013-00187
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE BLADE WAS NOT FUNCTIONAL COULD NOT BE CONFIRMED. THE VISUAL INVESTIGATION OF THE RETURNED SCREWDRIVER BLADE SHOWED STRONG DAMAGES AT THE WORKING PART. IT WAS DETERMINED THAT THE EDGES OF THE BLADE WINGS ARE HEAVILY PLASTICALLY DEFORMED AND ROUNDED OUT DUE TO INSUFFICIENT INSERTION INTO THE SCREWS RECESS AND / OR SLIPPING OUT WHILE APPLYING TOO HIGH TORSIONAL FORCES. WHEN ENGAGING THE SCREW, AXIAL PRESSURE OF THE SCREWDRIVER INTO THE SCREW HEAD MUST BE ADEQUATELY APPLIED TO ENSURE THAT THE BLADE IS FULLY INSERTED INTO THE SCREW HEAD. THIS RESULTS IN PROPER AXIAL ALIGNMENT AND FULL CONTACT BETWEEN DRIVER AND SCREW, MINIMIZING THE RISKS OF DAMAGE. THE FUNCTIONAL TEST WITH TWO NEW TEST SCREWS (ARTICLE # 52-20404 - RELATED TO THE SYSTEM), EXECUTED WITH THE MANUFACTURING DEPARTMENT, SHOWED THAT THE PICKING UP OF ALL NEW TEST SCREWS UPON TO THE RETURNED BLADE COULD BE PERFORMED CORRECTLY. THE SUBSEQUENT MANUAL VIBRATION TEST OF THE CONNECTED SCREWS UPON TO THE RETURNED BLADE IN THE AIR, PERFORMED BY HAND, SHOWED THAT THE BLADE HELD THE PICKED UP SCREWS SECURELY. THE FOLLOWING FUNCTIONAL PULL OFF FORCE TEST, PERFORMED ACCORDING TO THE INSPECTION PLAN, REVEALED THAT THE MEASURED PULL OFF FORCE VALUES OF THE TWO NEW TEST SCREWS UPON TO THE RETURNED BLADE MET THE SPECIFIED TOLERANCE OF 20-60N. FINALLY, BASED ON INVESTIGATION THE ROOT CAUSE FOR THE REPORTED EVENT - DIFFICULTIES WITH THE ENGAGEMENT OF THE SCREWDRIVER BLADE AND THE HEAD OF THE SCREW AS WELL AS THE STRIPPING OF THE HEADS OF THE SCREWS - MAY HAVE BEEN THE IMPROPER USER´S TECHNIQUE COMPARED TO THE DETERMINED DETERIORATIONS IN COMBINATION WITH TORSIONAL OVERLOAD DURING APPLICATION LEADING TO THE FACT THAT THE BLADES SLIPPED OUT OF THE SCREW HEADS AS WELL AS ENGAGEMENT PROBLEMS BETWEEN BLADE AND SCREW HEAD. PRIMARILY, THE SCREWDRIVER BLADE NEEDS TO BE INSERTED PERPENDICULAR INTO THE CROSS RECESS OF THE SCREW HEAD AND SECONDLY, THE AXIAL PRESSURE OF THE SCREWDRIVER BLADE INTO THE SCREW HEAD MUST BE ADEQUATELY APPLIED TO ENSURE THAT THE BLADE IS FULLY AND DEEP ENOUGH INSERTED INTO THE CROSS RECESS. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTION IS CURRENTLY REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SMART LOCK SURGERY, AT SCREW INSERTION THE BLADE WAS NOT FUNCTIONAL BECAUSE IT CAME OFF MANY TIMES FROM THE SCREW HEAD.

    Description of Event or Problem · 1

    DURING SMART LOCK SURGERY, AT SCREW INSERTION THE BLADE WAS NOT FUNCTIONAL BECAUSE IT CAME OFF MANY TIMES FROM THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386471 2.7/3.0MM CROSS-PIN BLADE, WITH HEXAGONAL SHAFT END INSTRUMENT LXH STRYKER LEIBINGER FREIBURG Y11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other