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.

This article briefly introduces the concepts of failure analysis and root cause analysis (RCA), and the role of failure analysis as a general engineering tool for enhancing product quality and failure prevention. It reviews four fundamental categories of physical root causes, namely, design deficiencies, material defects, manufacturing/installation defects, and service life anomalies, with examples. The article describes several common charting methods that may be useful in performing an RCA. It also discusses other failure analysis tools, including review of all sources of input and information, people interviews, laboratory investigations, stress analysis, and fracture mechanics analysis. The article concludes with information on the categories of failure and failure prevention.

This article briefly introduces the concepts of failure analysis, including root-cause analysis (RCA), and the role of failure analysis as a general engineering tool for enhancing product quality and failure prevention. It initially provides definitions of failure on several different levels, followed by a discussion on the role of failure analysis and the appreciation of quality assurance and user expectations. Systematic analysis of equipment failures reveals physical root causes that fall into one of four fundamental categories: design, manufacturing/installation, service, and material, which are discussed in the following sections along with examples. The tools available for failure analysis are then covered. Further, the article describes the categories of mode of failure: distortion or undesired deformation, fracture, corrosion, and wear. It provides information on the processes involved in RCA and the charting methods that may be useful in RCA and ends with a description of various factors associated with failure prevention.

While there are many fracture mechanisms that can lead to the failure of a plastic component, environmental stress cracking (ESC) is recognized as one of the leading causes of plastic failure. This article focuses on unpacking the basic concepts of ESC to provide the engineer with a better understanding of how to evaluate and prevent it. It then presents factors that affect and contribute to the susceptibility of plastic to ESC: material factors, chemical factors, stress, and environmental factors. The article includes the collection of background information to understand the circumstances surrounding the failure, a fractographic evaluation to assess the cracking, and analytical testing to evaluate the material, design, manufacturing, and environmental factors.

Corrosion is the deterioration of a material by a reaction of that material with its environment. The realization that corrosion control can be profitable has been acknowledged repeatedly by industry, typically following costly business interruptions. This article describes the electrochemical nature of corrosion and provides the typical analysis of environmental- and corrosion-related failures. It presents common methods of testing of laboratory corrosion and discusses the processes involved in the prevention of environmental- and corrosion-related failures of metals and nonmetals.

This article discusses technologies focused on processing plastic materials or producing direct tools used in plastics processing. The article focuses on extrusion and injection molding, covering applications, materials and their properties, equipment, processing details, part design guidelines, and special processes. It also covers the functions of the extruder, webline handling, mixing and compounding operations, and process troubleshooting. Thermoforming and mold design are covered. Various other technologies for polymer processing covered in this article are blow molding, rotational molding, compression molding, transfer molding, hand lay-up process, casting, and additive manufacturing.