VARIAX DR AIMING BLOCK FIXATION PIN

Additional Manufacturer Narrative

AS PER VISUAL INVESTIGATION, IT WAS DETERMINED THAT THE STOP PIN WAS BROKEN DUE TO TOO HIGH BENDING FORCES AND THEREFORE IT GOT DETACHED. THE FRACTURED SURFACE OF THE WELDING SEAM SHOWED THE APPEARANCE OF A FORCED RUPTURE. THE GEOMETRY OF THE WELDING SEAM INDICATED THAT THE LASER-WELDING SEAM WAS CORRECTLY PERFORMED. MOREOVER, THE STOP BAR OF THE SCREW HAD HEAVY PLASTIC DEFORMATIONS DUE TO THE COLLISION AND FRICTION WITH THE STOP PIN. SINCE HIGH TORSIONAL FORCES ACTED DURING THE APPLICATION, HIGH BENDING FORCES ALSO OCCURRED UPON THE STOP PIN, FINALLY LEADING TO THE BREAKAGE OF THE LASER-WELDING SEAM. THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUE.

Description of Event or Problem

IT WAS FOUND THAT THE STOP PIN OF THE FIXATION PIN HAD BROKEN WHEN IT WAS CHECKED UPON INSPECTION OF THE RETURNED LONER KIT FROM THE HOSPITAL. THE STOP PIN WAS LOST.