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Failure Mode

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  1. F G H K L M I A B C D E Fault Tree Analysis Ver. 5 April 21, 2008 Team Members: Adrienne Belasco, Mitch Barnett, Urvi Patel, Dan Wilkinson Advisors: Richard Debski, PhD, Jan Grudziak, MD, PhD, Prerana Patel, MD Failure Mode Implementation Failure Design Failure

  2. A The screw does not improve healing conditions for the patient preexisting patient condition.

  3. B Improper fitting between screw and removal device Machining Errors in Precision

  4. Contamination during surgical implantation C The screw causes an infection Rejection of the material Material Biocompatibility Patient allergy

  5. D Loosening of scews, decreased stability, and prolonged bone healing Vibration and shock during bone regeneration period post-removal surgery

  6. E Screw shaft breaks due to high torques during removal Bone regeneration results in higher bone-screw adhesion than normal

  7. F Torque generated by the surgeon is more than 10 Nm Bone regeneration results in higher bone-screw adhesion than normal

  8. G Possible screw failure during bone regeneration period Surgeon place the screw at the wrong angle, resulting in added stress Bone regeneration results in higher bone-screw adhesion than normal

  9. H Reduced effectiveness of screw in the alignment of the regenerating bone Pharmaceuticals may weaken bone

  10. I Overgrowth of the bone results in inability to use removal device Natural bone regeneration

  11. K Screw Stripping Bone regeneration results in higher than normal bone-screw adhesion

  12. L Removal device breaks due to high torques during removal Bone regeneration results in higher bone-screw adhesion than normal

  13. M Screw breakage in vivo Weakening of screw due to removal of material for second hexagonal socket