Ultrasonic cleaning is widely used in the production of medical devices such as guide wires and vascular implants. There are many cases, however, where cleaning frequencies have been close to the natural frequency of the device, producing resonant vibrations large enough to cause damage or premature failure. Several cases of ultrasonic cleaning-induced fatigue and corresponding failures of medical devices are examined in this review. Preventative measures to ensure that ultrasonic cleaning frequencies do not pose a threat are also provided.

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 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.

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.

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.

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.

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.

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.

A design may be improvable without presenting an unacceptable risk related to safety or performance. However, design-related failures can result from an oversight in performing one of the major design activities or from a failure to balance the competing demands inherent to part design. This article focuses on design-related failures in products utilizing polymeric materials, and reviews important considerations of the design envelope of plastic parts. The article provides a non-exhaustive list and descriptions of design tools that can support the design process and the prevention of design-related failures. It also discusses the most common causes of design-related failures of plastic parts. The article can assist in both failure analysis and in the prevention of failures in which design may be a contributing factor or a root cause.

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.

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.

Two of four adjustable Moore pins, which had been used to stabilize a proximal femur fracture, were found to be broken and deformed at their threads. The pins were made from a cobalt-chromium alloy and were not in the same condition. Brittle precipitates in the grains and grain boundaries were seen in one of the pins and hence the fracture was revealed to have occurred along the grain boundaries. The other pin made from cold-worked cobalt-chromium alloy was observed to have randomly lines of primary inclusions. Intermingled dimples and fatigue striations were exhibited on the fracture surface of this pin. Thus, the effect of different conditions of cobalt-chromium alloys on failure behavior was demonstrated as a result of this study.

The pointed ends of several stainless steel forceps split or completely fractured where split portions broke off. All the forceps were delivered in the same lot. The pointed ends of the forceps are used for probing and gripping very small objects and must be true, sound, and sharp. Analysis supported the conclusion that the failures to be the result of seams in the steel that were not joined during hot working. Recommendations included that closer inspection of the product take place at all stages of manufacturing. Inspection at the mill will minimize discrepancies at the source, and the inspection of the finished product will help detect obscure seams.

A type 316L stainless steel angled plate failed. The fatigue fracture was found to have occurred at a plate hole. Symmetric cyclic bending forces were revealed by the fatigue damage at the fracture edge at the top surface of the plate. Fatigue striations and slip bands produced on the surface during cyclic loading were observed. The material was showed by the deformation structure to be in the cold-worked condition and was termed to not be the cause of the implant failure.

During the internal fixation, the type 316LR stainless steel cortical bone screw failed. Extensive spiral deformation was revealed by the fracture surface. Dimple structure characteristic of a ductile failure mode was observed with dimples oriented uniformly in the deformation direction. A zone of heavily deformed grains at the fracture edge was revealed by longitudinal metallographic examination. The shearing fractures of a commercially pure titanium screw and a cast cobalt-chromium-molybdenum alloy were discussed for purpose of comparison.