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.

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.

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.

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 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.

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.

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 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.

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.

Wear on a titanium screw head with a lip of material that that was transported by fretting at a plate-hole edge was studied. A flat fretting zone was visible on the screw surface over the material lip. A cellular wear structure containing wear debris was found. No morphological signs of corrosion were observed in connection with fretting structures.

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.

Heavy pitting corrosion on type 304 stainless steel bone screw was studied. A screw head that exhibited heavy pitting corrosion attack was observed. Deep tunnels that penetrated the screw head and followed the inclusion lines were revealed. The screw was inserted in a plate made of type 316LR stainless steel and some mechanical fretting and very few corrosion pits were revealed. Type 304 stainless steel was deemed not to be satisfactory as an implant material.

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.

Fretting and fretting corrosion at the contact area between the screw hole of a type 316LR stainless steel bone plate and the corresponding screw head was studied. The attack on the 316LR stainless steel was only shallow. Mechanical grinding and polishing structures were exhibited by a large portion of the contact area. Fine corrosion pits in the periphery were observed and intense mechanical material transfer that can take place during fretting was revealed. Smearing of material layers over each other during wear was observed and attack by pitting corrosion was interpreted to be possible.

This article reviews generalized test methodologies for fatigue characterization of polymers and examines fatigue fracture mechanisms in different engineering plastics. It provides detailed micromechanistic images of crack-tip processes for a variety of semicrystalline and amorphous engineering polymers. The article describes fracture mechanics solutions and approaches to the fatigue characterization of engineering polymers when dealing with macroscale fatigue crack growth. It includes mechanistic images for high-density polyethylene, ultrahigh-molecular-weight polyethylene, nylon 6, 6, polycarbonate, and polypropylene. The article describes the micromechanisms of toughening of plastics and uses a macroscale approach of applying fracture mechanics to the fatigue life prediction of engineering polymers, building on the mechanistic concepts. It also describes the factors affecting fatigue performance of polymers.

A large portion of the four-hole Lane plate disintegrated and consisted mainly of corrosion products after remaining in the body for 26 years. Transformation structures and carbides were exhibited by the plate which was made from chromium steel. Minimal corrosion was exhibited by the soft austenitic 304 stainless steel used to make the screws. The corrosion products of the plate were revealed by microprobe analysis to impregnate the surrounding tissues. Improper material selection was concluded to be the reason for the general corrosion behavior.