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Cassio Barbosa, Ibrahim de Cerqueira Abud, Tatiana Silva Barros, Sheyla Santana de Carvalho, Ieda Maria Vieira Caminha
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Orthopedic fixation devices
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Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
Abstract
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.
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.9781627083294
EISBN: 978-1-62708-329-4
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001801
EISBN: 978-1-62708-241-9
Abstract
Both rods in a Harrington rod cervical stent failed after a short time in service. Metallurgical analysis revealed a significant number of notches as well as enlarged grain size in one of the two rods, rough shallow-cracked surfaces along the bend profiles, possible signs of corrosion, and fractures (on both rods) near indentations imparted by retaining clamps. The observations suggest that surface roughness and bending defects initiated cracking that led to the fatigue failure of the compromised rod, followed some time later by the overload fracture of the second rod.
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001802
EISBN: 978-1-62708-241-9
Abstract
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.
Book Chapter
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001804
EISBN: 978-1-62708-241-9
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048413
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048403
EISBN: 978-1-62708-226-6
Abstract
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.
Book Chapter
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048407
EISBN: 978-1-62708-226-6
Abstract
The plate used to treat a pseudarthrosis in the proximal femur was investigated for reasons of non-progress of healing. Fatigue cracks were revealed on the top surface of the small section of the plate at the fifth screw hole. The plate was found to be heavily loaded by comparison of intensity of these structures, compared to results of systematic crack-initiation experiments. It was revealed by fatigue bending tests that the fatigue life of plates with asymmetrically arranged holes is at least as long as for plates with holes situated in the center. Fatigue began at the large section only after a fatigue crack begins to propagate into the small plate section. A large secondary crack which had developed parallel to the main crack in the center of the surface was revealed. The fifth hole was situated at the transition between the supporting bone and the defect and hence stress concentration was revealed to be high.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048420
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001579
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048397
EISBN: 978-1-62708-226-6
Abstract
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.
Book Chapter
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048405
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048400
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048419
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0089543
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048421
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001573
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048410
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001606
EISBN: 978-1-62708-226-6
Abstract
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.
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001664
EISBN: 978-1-62708-226-6
Abstract
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.
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