Superelastic nitinol wires that fractured under various conditions were examined under a scanning electron microscope in order to characterize the fracture surfaces, produce reference data, and compare the findings with prior published work. The study revealed that nitinol fracture modes and morphologies are generally consistent with those of ductile metals, such as austenitic stainless steel, with one exception: Nitinol exhibits a unique damage mechanism under high bending strain, where damage occurs at the compression side of tight bends or kinks while the tensile side is unaffected. The damage begins as slip line formation due to plastic deformation, which progresses to cracking at high strain levels. The cracks appear to initiate from slip lines and extend in shear (mode II) manner.

Mechanical springs are used in mechanical components to exert force, provide flexibility, and absorb or store energy. This article provides an overview of the operating conditions of mechanical springs. Common failure mechanisms and processes involved in the examination of spring failures are also discussed. In addition, the article discusses common causes of failures and presents examples of specific spring failures, describes fatigue failures that resulted from these types of material defects, and demonstrates how improper fabrication can result in premature fatigue failure. It also covers failures of shape memory alloy springs and failures caused by corrosion and operating conditions.

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.

Failures of four different 300-series austenitic stainless steel biomedical fixation implants were examined. The device fractures were observed optically, and their surfaces were examined by scanning electron microscopy. Fractography identified fatigue to be the failure mode for all four of the implants. In every instance, the fatigue cracks initiated from the attachment screw holes at the reduced cross sections of the implants. Two fixation implant designs were analyzed using finite-element modeling. This analysis confirmed the presence of severe stress concentrations adjacent to the attachment screw holes, the fatigue crack initiation sites. Conclusions were reached regarding the design of these types of implant fixation devices, particularly the location of the attachment screw holes. The use of austenitic stainless steel for these biomedical implant devices is also addressed. Recommendations to improve the fixation implant design are suggested, and the potential benefits of the substitution of titanium or a titanium alloy for the stainless steel are discussed.

This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis of IPT, in Brazil. Investigation revealed that most of the samples were not in accordance with ISO standards and presented evidence of corrosion assisted fracture. Additionally, some components were found to contain fabrication/processing defects that contributed to premature failure. The implant of nonbiocompatible materials results in immeasurable damage to patients as well as losses for the public investment. It is proposed that local sanitary regulation agencies create mechanisms to avoid commercialization of surgical implants that are not in accordance with standards and adopt the practice of retrieval analysis of failed implants. This would protect the public health by identifying and preventing the main causes of failure in surgical implants.

The purpose of this article is to assist the reader in understanding the role that an engineering expert witness plays in evaluating incidents related to product liability, so that he or she may become better acquainted with the role that an engineer plays in such litigation. The topics covered are admissibility of expert opinions, how to evaluate data, factual evidence, mandatory and voluntary standards, physical evidence, medical records, scientific literature, design decisions evaluation, environment of use, user's contribution, reports of opposing experts, report of findings, and deposition and trial testimonies.

Metallurgical SEM analysis provides many insights into the failure of biomedical materials and devices. The results of several such investigations are reported here, including findings and conclusions from the examination a total hip prosthesis, stainless steel and titanium compression plates, and hollow spinal rods. Some of the failure mechanisms that were identified include corrosive attack, corrosion plus erosion-corrosion, inclusions and stress gaps, production impurities, design flaws, and manufacturing defects. Failure prevention and mitigation strategies are also discussed.

Several surgical tool failures were analyzed to understand why they occur and how to prevent them. The study included drills, catheters, and needles subjected to the rigors of biomedical applications such as corrosive environments, high stresses, sterilization, and improper cleaning procedures. Given the extreme conditions to which surgical tools can be exposed, and the potential for misuse, failures are inevitable and systematic methods for analyzing them are necessary to keep them in check.

This investigation characterizes five surgical stainless steel piercings and one niobium piercing that caused adverse reactions during use, culminating with the removal of the jewelry. Chemical composition shows that none of the materials are in accordance with ISO standards for surgical implant materials. Additionally, none of the stainless steel piercings passed the pitting-resistance criterion of ISO 5832-1, which implies that [%Cr + 3.3(%Mo)] > 26. Under microscopic examination, most of the jewelry revealed the intense presence of linear irregularities on the surface. The lack of resistance to pitting corrosion associated with the poor surface finishing of the stainless steel jewelry may induce localized corrosion, promoting the release of cytotoxic metallic ions (such as Cr, Ni, and Mo) in the local tissue, which can promote several types of adverse effects in the human body, including allergic reactions. The adverse reaction to the niobium jewelry could not be directly associated with the liberation of niobium ions or the residual presence of cytotoxic elements such as Co, Ni, Mo, and Cr. The poor surface finish of the niobium jewelry seems to be the only variable of the material that may promote adverse reactions.

The scanning electron microscope (SEM) is one of the most versatile instruments for investigating the microscopic features of most solid materials. The SEM provides the user with an unparalleled ability to observe and quantify the surface of a sample. This article discusses the development of SEM technology and operating principles of basic systems of SEM. The basic systems covered include the electron optical column, signal detection and display equipment, and the vacuum system. The processes involved in the preparation of samples for observation using an SEM are described, and the application of SEM in fractography is discussed. The article covers the failure mechanisms of ductile failure, brittle failure, mixed-mode failure, and fatigue failure. Lastly, image dependence on microscope type and operating parameters is also discussed.

A failure analysis was conducted on a flow-sensing device that had cracked while in service. The polysulfone sensor body cracked radially, adjacent to a molded-in steel insert. This article describes the investigative methods used to conduct the failure analysis. The techniques utilized included scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, thermomechanical analysis, and melt flow rate determination. It was the conclusion of the investigation that the part failed via brittle fracture, with evidence also indicating low cycle fatigue associated with cyclic temperature changes from normal service. The design of the part and the material selection were significant contributing factors because of stresses induced during molding, physical aging of the amorphous polysulfone resin, and the substantial differential in coefficients of thermal expansion between the polysulfone and the mating steel insert.

This article provides an overview of metal additive manufacturing (AM) processes and describes sources of failures in metal AM parts. It focuses on metal AM product failures and potential solutions related to design considerations, metallurgical characteristics, production considerations, and quality assurance. The emphasis is on the design and metallurgical aspects for the two main types of metal AM processes: powder-bed fusion (PBF) and directed-energy deposition (DED). The article also describes the processes involved in binder jet sintering, provides information on the design and fabrication sources of failure, addresses the key factors in production and quality control, and explains failure analysis of AM parts.

This article focuses on the general methods and approaches from the perspective of a reconstruction analyst and includes discussions relevant to materials failure analysts at the incident scene. The elements of accident reconstruction are described. These have conceptual similarity with the principles for failure analysis of material incidents that are less complex than a large-scale accident. The article provides a brief review of some general concepts on the use of modeling which can be a very powerful tool for information pertaining to the reconstruction of an accident where the model can be a physical, mathematical, or logical representation of a physical system or process.

This article commences with a summary of fatigue processes and mechanisms. It focuses on fractography of fatigue. Characteristic fatigue fracture features that can be discerned visually or under low magnification are described. Typical microscopic features observed on structural metals are presented subsequently, followed by a brief discussion of fatigue in nonmetals. The article reviews the various macroscopic and microscopic features to characterize the history and growth rate of fatigue in metals. It concludes with a description of fatigue of polymers and composites.

The article commences with an overview of short-term and long-term mechanical properties of polymeric materials. It discusses plasticization, solvation, and swelling in rubber products. The article further describes environmental stress cracking and degradation of polymers. It illustrates how surface degradation of a plain strain tension specimen alters the ductile brittle transition in polyethylene creep rupture. The article concludes with information on the effects of temperature on polymer performance.

Failure analysis is generally defined as the investigation and analysis of parts or structures that have failed or appeared to have failed to perform their intended duty. Methods of field inspection and initial examination are also critical factors for both reconstruction analysts and materials failure analysts. This article focuses on the general methods and approaches from the perspective of a reconstruction analyst. It describes the elements of accident reconstruction, which have conceptual similarity with the principles for failure analysis of material incidents that are less complex than a large-scale accident. The approach presented is that the analysis and reconstruction is based on the physical evidence. The article provides a brief review of some general concepts on the use and limitations of advanced data acquisition tools and computer modeling. Legal implications of destructive testing are discussed in detail.

Fatigue failure of engineering components and structures results from progressive fracture caused by cyclic or fluctuating loads. Fatigue is an important potential cause of mechanical failure, because most engineering components or structures are or can be subjected to cyclic loads during their lifetime. This article focuses on fractography of fatigue. It provides an abbreviated summary of fatigue processes and mechanisms: fatigue crack initiation, fatigue crack propagation, and final fracture,. Characteristic fatigue fracture features that can be discerned visually or under low magnification are then described. Typical microscopic features observed on structural metals are presented subsequently, followed by a brief discussion on fatigue in polymers and polymer-matrix composites.

This article commences with a description of the prosthetic devices and implants used for internal fixation. It describes the complications related to implants and provides a list of major standards for orthopedic implant materials. The article illustrates the body environment and its interactions with implants. The considerations for designing internal fixation devices are also described. The article analyzes failed internal fixation devices by explaining the failures of implants and prosthetic devices due to implant deficiencies, mechanical or biomechanical conditions, and degradation. Finally, the article discusses the fatigue properties of implant materials and the fractures of total hip joint prostheses.

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.