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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
... 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...
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
... discussed. orthopedic implant devices fracture corrosion inclusions and stress gaps medical materials cracking fretting pitting fractography fracture toughness Ti6Al4V (titanium-aluminum-vanadium alloy) UNS R56406 316L stainless steel (austenitic wrought stainless steel) UNS S31603...
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
... three to four times the weight of the patient, while cyclic loads can total up to 3 × 10 6 cycles per year. 4 The premature failure of metallic implants can be influenced by several factors, including mechanical design, material selection, manufacturing practice, medical installation procedure...
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001841
EISBN: 978-1-62708-241-9
... B.A. , Medical Device Failure Analysis , Materials for Medical Devices , Vol 23 , ASM Handbook , Narayan R.J. , Ed., ASM International , 2012 , p 343 – 359 . 10.31399/asm.hb.v23.a0005657 • T. Service , Finite Element Modeling in Failure Analysis , Failure Analysis...
Series: ASM Failure Analysis Case Histories
Volume: 3
Publisher: ASM International
Published: 01 December 2019
DOI: 10.31399/asm.fach.v03.c9001805
EISBN: 978-1-62708-241-9
... ) 5. Nitronic 60 Brochure, High Performance Alloys, Inc. , www.hpalloy.com Selected references Selected references • James B.A. , Medical Device Failure Analysis , Materials for Medical Devices , Vol 23 , ASM Handbook , Narayan R.J. , Ed., ASM International , 2012...
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006832
EISBN: 978-1-62708-329-4
.... The topics covered are admissibility of expert opinions, how to evaluate data, factual evidence, mandatory and voluntary standards, physical evidence, medical records, scientific literature, design decisions evaluation, environment of use, user's contribution, reports of opposing experts, report of findings...
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.homegoods.c9001610
EISBN: 978-1-62708-222-8
... Dimethylgyoxime Test Goes Detecting Release of Nickel from Earrings,” Sci. Total Environ. , 1998 , 224 , pp. 161 – 5 . 7. Anon : in Implants for Surgery - Metallic Materials - Parts 1–12 , International Organization for Standardization , ISO 5832-1 to ISO 5832-12, Geneve . 8. Anon : Medical...
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.c9001802
EISBN: 978-1-62708-241-9
... • James B.A. , Medical Device Failure Analysis , Materials for Medical Devices , Vol 23 , ASM Handbook , Narayan R.J. , Ed., ASM International , 2012 , p 343 – 359 . 10.31399/asm.hb.v23.a0005657 • Hodgson D.E. , Wu M.H. and Biermann R.J. , Shape Memory Alloys...
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006836
EISBN: 978-1-62708-329-4
... Wires Used in Medical Applications In some instances of spring failure, the cause is not evident, even after an exhaustive examination of material, processing, and design factors. When a thorough investigation in these areas does not reveal the cause, it is necessary to investigate operating...
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
... for a mechanical device and should not be tolerated in a medical application where the comfort and well-being of an injured human is at issue. Would simply a material change prevent fatigue failures of the type observed in these fixation devices? Of course, it can never be predicted with absolute certainty...
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.modes.c9001593
EISBN: 978-1-62708-234-1
... indicating low cycle fatigue associated with cyclic temperature changes from normal service. The design of the part and the material selection were significant contributing factors because of stresses induced during molding, physical aging of the amorphous polysulfone resin, and the substantial differential...
Series: ASM Handbook
Volume: 11
Publisher: ASM International
Published: 15 January 2021
DOI: 10.31399/asm.hb.v11.a0006769
EISBN: 978-1-62708-295-2
...Abstract Abstract The scanning electron microscope (SEM) is one of the most versatile instruments for investigating the microscopic features of most solid materials. The SEM provides the user with an unparalleled ability to observe and quantify the surface of a sample. This article discusses...
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 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...
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
... 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. Inclusions Surgical implants 304 UNS S30400 Pitting corrosion Figure 1 shows a screw head...
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
... 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. Cyclic loads Slip bands Surgical implants 316L UNS S31603 Fatigue fracture Figure...
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
... 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...
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...
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 material meets ISO and ASTM F 318 Special Quality specifications. The screws were used with a relatively rigid plate to treat a fracture complication in the upper end of the femur. Radiographs indicated various signs of unstable fixation, which explains the fatigue failures. The two screws were situated...
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 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...