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.

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.

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.

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.

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.

Type 316LR stainless steel screws that failed by fatigue were studied. It was found that fatigue fracture can occur on different thread levels, depending on the loading situation. The initiation of secondary fatigue cracks was occasionally found parallel to the fracture plane. The screws were used with a relatively rigid plate to treat a fracture complication in the upper end of the femur. The fatigue failures were explained by signs of unstable fixation revealed by radiographs.

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.

Threads of a bone screw (Co-Cr-Mo alloy, type ASTM F75) had broken off, and other threads had cracked. 15x sectioning showed porosity, and 155x magnification showed gas holes, segregation, and dissolved oxides. This supports the conclusion that manufacturing defects caused the failure.

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.

A narrow bone plate made of type 316 stainless steel and used to stabilize an open midshaft femur fracture failed. A crack at a plate hole next to the fracture site had been revealed by a radiograph taken 13 weeks after the operation. The plate was revealed to be slightly bent in the horizontal plane, and the fracture gap was considerably open. The screws and plates supplied by different manufacturers were revealed to be different with respect to microcleanliness (primary inclusion content) of the materials and only one of them was found to be according to specifications. The local crack formation was influenced by the presence of larger inclusions. The screw failed was revealed to have failed through a fatigue mechanism by the presence of striations in the scanning electron micrograph. The crack in the plate was revealed to have originated at the upper, outer corner of the plate by the beach marks which indicated the action of asymmetric bending and rotational forces.

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.