This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.
Brad A. James, Medical Device Failure Analysis, Materials for Medical Devices, Vol 23, ASM Handbook, Edited By Roger J. Narayan, ASM International, 2012, p 343–359, https://doi.org/10.31399/asm.hb.v23.a0005657
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