Six Sigma Analysis of Mini-Plate Fixation Systems Used in Human Mandible Fractures: A Clinical Case Study of Symphysis Fracture

Abstract

The objective of Six Sigma Analysis (SSA) is to determine the robustness level of a current design, process or system considering the expected range of an input parameter. This strategy has been successfully applied to several fields, including healthcare management. This work presents a novel study of SSA to assess the mini-plate fixation employed for mandible fracture. The objective is to reflect the number of concerns in a surgical operation case by performing a statistical measurement of operation capability. A three-dimensional finite element model of a clinical case is elaborated. Some muscles may be severed or damaged during surgery and unable to function to their full potential. To obtain reliable designs, these muscle forces are considered as random variables. The Six Sigma analysis is used to determine if the output parameters satisfy the Six Sigma quality criteria or not. The remarked potential failure modes in this study are found to be similar to those found in a previous reliability study that was applied to the same clinical case. According to the results of SSA, the assessment level (2.462 << 6) means that much of the data are outside of the demand, and require several improvements to ensure patient satisfaction.