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.

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.

TiN coated back surgery wires were made of Ti-6Al-4V. The reported failure was the presence of pits located in the uncoated area of the wires. The uncoated area of the wire is where the wire is fixtured in the coating chamber during coating. Examination and analysis of the pits using SEM/EDX detection unit revealed significant peaks of B, O, Zr and Fe. Moreover, the shape of the pits was similar to an arc crater. The formation of pits in the wire was caused during coating due to microarcing. A contaminated fixture used during the coating most likely caused the microarcing.

Cerclage wire, which was used with two screws and washers for a tension band in a corrective internal fixation, was found broken at several points and corroded after nine months in service. The material was examined using energy-dispersive x-ray analysis and determined not to be in compliance with standards (type 304 stainless steel without molybdenum). The screws and washers were found to be made of remelted implant-quality type 316L stainless steel and were intact. Signs of sensitization, characterized by chromium carbide precipitates at the grain boundaries, were revealed by the microstructure. Intercrystalline corrosion with pitted grains was indicated by SEM fractography. Improper heat treatment of the steel was interpreted to have led to intercrystalline corrosion and implant separation.

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.

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.

Two type 316L stainless steel orthopedic screws broke approximately 6 weeks after surgical implant. The screws had been used to fasten a seven-hole narrow dynamic compression plate to a patient's spine. The broken screws and screws of the same vintage and source were examined using macrofractography, SEM fractography, and hardness testing. Fractography established that fracture was by fatigue and that the fatigue cracking originated at corrosion pits. Hardness while below specification, still indicated that the screws were in the cold-worked condition and notch sensitive during fatigue loading. Use of a steel with a higher molybdenum content (317L) in the annealed condition was recommended.

A compression hip screw is a device designed to hold fractures in the area of the femur in alignment and under compression. A side plate, which is an integral part of the device, is attached by screws to the femur, and it holds the compression screw in position. The device analyzed had broken across the eighth hole (of nine holes) from the end of the plate. The detailed metallurgical failure analysis of the device, including metallography and fractography, is reported here. It was found that the device had adequate metallurgical integrity for the application for which it was intended. It is believed that failure was caused by the lack of a screw in the ninth hole. Evidence is also presented which indicates that the device was bent prior to insertion, and the local plastic deformation may have caused structural changes leading to premature crack initiation.

A stainless steel screw securing an orthopedic implant fractured and was analyzed to determine the cause. Investigators used optical and scanning electron microscopy to examine the fracture surfaces and the microstructure of the austenitic stainless steel from which the screw was made. The results of the study indicated that the screw failed due to fatigue fracture stemming from surface cracks generated by stress concentration likely caused by grooves left by improper machining.

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.

A type 316L stainless steel “Jewett nail” hip implant failed after 2 months of service. Fracture occurred through the first of five screw holes in the plate section. Microscopic examination of mating fracture surfaces showed that failure had initiated at the outside (convex) surface of the plate and proceeded through its thickness. The fracture morphology was characteristic of fatigue. A beveled area on the inside surface of the plate indicated that the implant had been fractured for some time prior to removal. Metallographic examination of samples cut from the plate section revealed a series of hidden repair welds on the inside surface of the plate in the vicinity of the fracture. Comparison of the microstructure in the area of the fracture with that in an area away from the weld indicated that the repair welding had resulted in the creation of an annealed, softened zone. Manufacturers should never attempt to salvage this type of critical device by welding or any other procedure that might compromise its integrity.

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 bone cement failed at the distal end of the prosthesis stem of femoral head prosthesis six months after implantation. A small indentation on the lateral contour of the stem was visible where the stem had broken. The degree of loosening (gap between the lateral stem contour and the bone or cement) and implant loading was revealed by the dislocation of fragments of the prosthesis. Secondary cracks that had originated at the lateral aspect of the stem were revealed by metallographic examination of a section parallel to the stem surface and perpendicular to the fracture surface of the distal fragment. Gas pores are apparent in the grain and at the grain boundaries were revealed by a transverse section. Fine parallel line structures that run diagonally through the fractograph may be slip traces were revealed by scanning electron microscopy. One of the cracks was revealed to have propagated through a larger gas pore by a ruptured gas pore. The stresses created through the fatigue process activated glide systems which served the formation of secondary cracks along glide planes.

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.

Stainless steel is frequently used for bone fracture fixation in spite of its sensitivity to pitting and cracking in chloride containing environments (such as organic fluids) and its susceptibility to fatigue and corrosion fatigue. A 316L stainless steel plate implant used for fixation of a femoral fracture failed after only 16 days of service and before bone callus formation had occurred. The steel used for the implant met the requirements of ASTM Standard F138 but did contain a silica-alumina inclusion that served as the initiation point for a fatigue/corrosion fatigue fracture. The fracture originated as a consequence of stress intensification at the edge of a screw hole located just above the bone fracture; several fatigue cracks were also observed on the opposite side of the screw hole edge. The crack propagated in a brittle-like fashion after a limited number of cycles under unilateral bending. The bending loads were presumably a consequence of leg oscillation during assisted perambulation.

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 addresses the forms of corrosion that contribute directly to the failure of metal parts or that render them susceptible to failure by some other mechanism. It describes the mechanisms of corrosive attack for specific forms of corrosion such as galvanic corrosion, uniform corrosion, pitting and crevice corrosion, intergranular corrosion, and velocity-affected corrosion. The article contains a table that lists combinations of alloys and environments subjected to selective leaching and the elements removed by leaching.

Corrosion is the electrochemical reaction of a material and its environment. This article addresses those forms of corrosion that contribute directly to the failure of metal parts or that render them susceptible to failure by some other mechanism. Various forms of corrosion covered are galvanic corrosion, uniform corrosion, pitting, crevice corrosion, intergranular corrosion, selective leaching, and velocity-affected corrosion. In particular, mechanisms of corrosive attack for specific forms of corrosion, as well as evaluation and factors contributing to these forms, are described. These reviews of corrosion forms and mechanisms are intended to assist the reader in developing an understanding of the underlying principles of corrosion; acquiring such an understanding is the first step in recognizing and analyzing corrosion-related failures and in formulating preventive measures.

Polymer materials are key building blocks of the modern world, commonly used in packaging, automobiles, building materials, electronics, telecommunications, and many other industries. These commercial applications of polymeric materials would not be possible without the use of additives. This article is divided into five sections: mechanical property modifiers, physical property modifiers, biological function modifiers, processing aids, and colorants. It describes three classes of additives that are used to inhibit biological activity, six classes of mechanical property modifiers, three classes of physical property modifiers, and two classes of both colorants and processing aids.