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Failure Analysis of Medical Devices

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Abstract

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

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  1. Exponent, Inc, Menlo Park, California, USA

    Matthew Bowers, Gabriel Ganot, Louis Malito, Anyanwu Ezechukwu, Felicia Svedlund & Brad James

  2. Exponent, Inc., SpaceX, Hawthorne, California, USA

    Babak Kondori

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© 2021 ASM International. This article is reprinted with permission from Analysis and Prevention of Component and Equipment Failures, Vol 11A, ASM Handbook, Brett A. Miller, Roch J. Shipley, Ronald J. Parrington, Daniel P. Dennies, editors, ASM International, 2021, p 736–753, https://doi.org/10.31399/asm.hb.v11A.a0006811.

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Bowers, M., Ganot, G., Malito, L. et al. Failure Analysis of Medical Devices. J Fail. Anal. and Preven. 22, 154–180 (2022). https://doi.org/10.1007/s11668-021-01332-2

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  • DOI: https://doi.org/10.1007/s11668-021-01332-2

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