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.

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.

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.