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Series: ASM Failure Analysis Case Histories
Volume: 1
Publisher: ASM International
Published: 01 December 1992
DOI: 10.31399/asm.fach.v01.c9001097
EISBN: 978-1-62708-214-3
... Abstract 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...
Abstract
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.
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
... Plastic deformation Surgical implants 316L UNS S31603 Fatigue fracture Corrosion fatigue In fractures of and around the head of the femur, a compression hip screw surgical implant is sometimes employed to provide bone alignment and fixation during healing. Figure 1 shows schematically...
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.
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
.... 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. surgical screws fatigue fracture machining defects stainless steel cracking optical and scanning...
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 Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
... 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...
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 Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0048419
EISBN: 978-1-62708-226-6
... 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. Inclusions Surgical implants 304 UNS S30400 Pitting corrosion Figure 1 shows a screw head that exhibits...
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.c0048421
EISBN: 978-1-62708-226-6
... of corrosion were observed in connection with fretting structures. Surgical implants Wear particles Titanium Fretting wear Figure 1(a) shows a portion of a titanium screw head with a lip of material that was transported by fretting at a plate-hole edge. A flat fretting zone is visible...
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.
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
.... 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. Surgical implants 316LR Fatigue fracture Fatigue fracture can occur on different thread...
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.c0089543
EISBN: 978-1-62708-226-6
.... Bone screws Casting defects Screws Surgical implants ASTM F75 Casting-related failures Portions of the threads of the screw shown in Fig. 1(a) had broken off, and other threads had cracked. The screw was made from a cast Co-Cr-Mo alloy. A longitudinal section through the screw revealed gas...
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.c9001690
EISBN: 978-1-62708-226-6
... … balance Nitinol ASTM F2063-00 … … 0.05 max … 0.02 max … 54.5–57.0 balance (a) Undetermined The use of dissimilar metals (such as CP-Ti plate and Ti-6Al-4V alloy plate screws) in surgical implants is not recommended due to the possible formation of galvanic couple, which may...
Abstract
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.
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
..., these orthopedic devices are surgically implanted and affixed to bones, usually with screws of the same alloy composition. Fixation implants usually remain in the human body until the broken bone has healed sufficiently to sustain normal loading without the additional support provided by the implant. After several...
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.c0048397
EISBN: 978-1-62708-226-6
... 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. Carbides Corrosion products...
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.
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
... to be possible. Biochemistry Surgical implants Wear particles 316LR Pitting corrosion Figure 1 shows a plate hole with the area that was in contact with the screw head. In contrast to Example, the attack on this high-quality type 316LR stainless steel was only shallow. Figure 1(a) shows...
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.c0048410
EISBN: 978-1-62708-226-6
... 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...
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
Volume: 2
Publisher: ASM International
Published: 01 December 1993
DOI: 10.31399/asm.fach.v02.c9001264
EISBN: 978-1-62708-215-0
... the neck, across the fracture, and into the head. The plate portion rests on the shank of the femur and is affixed to it with screws. Pertinent Specifications The applicable specification at the time of manufacture was ASTM F55-66T, which pertains to stainless steel bars and wires for surgical...
Abstract
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.
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...
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.
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...
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.c0048399
EISBN: 978-1-62708-226-6
... on the fracture surface of this pin. Thus, the effect of different conditions of cobalt-chromium alloys on failure behavior was demonstrated as a result of this study. Grain boundaries Surgical implants ASTM F75 Brittle fracture Two of four adjustable Moore pins, which had been used to stabilize...
Abstract
Two of four adjustable Moore pins, which had been used to stabilize a proximal femur fracture, were found to be broken and deformed at their threads. The pins were made from a cobalt-chromium alloy and were not in the same condition. Brittle precipitates in the grains and grain boundaries were seen in one of the pins and hence the fracture was revealed to have occurred along the grain boundaries. The other pin made from cold-worked cobalt-chromium alloy was observed to have randomly lines of primary inclusions. Intermingled dimples and fatigue striations were exhibited on the fracture surface of this pin. Thus, the effect of different conditions of cobalt-chromium alloys on failure behavior was demonstrated as a result of this study.
Series: ASM Handbook Archive
Volume: 11
Publisher: ASM International
Published: 01 January 2002
DOI: 10.31399/asm.hb.v11.a0001819
EISBN: 978-1-62708-180-1
... holes. (i) Classical Bagby compression bone plate. (j) Cortical bone screw. (k) Cancellous bone screw (with shaft to produce compression). (l) Condylar angle blade plate. (m) Hip plate for osteotomies. (n) Jewett nail plate with three-flanged nail. (o) Two-component dynamic hip screw plate. (p...
Abstract
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.
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001803
EISBN: 978-1-62708-241-9
... deleterious effects on the body. Metallic materials such as stainless steel, 316L, cobalt-chromium alloys, and pure titanium and its alloys have been used for surgical implant materials. The α+β-type titanium alloy, such as Ti6Al4V, has been most widely used as an implant material for artificial hip joints...
Abstract
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.
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
.... 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...
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.
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