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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...
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
... microscopy strain nitinol (nickel-titanium shape memory alloy) UNS N01555 Introduction As the use of NiTi in medical devices increases, so too will the number of NiTi failures. Important information regarding the loading condition, fracture mode, and material performance can be determined from...
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.9781627082266
EISBN: 978-1-62708-226-6
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
... Abstract 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...
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Published: 01 January 2002
Fig. 9 Fracture in a thin medical device manufactured from type D 2 tool steel. (a) View showing a fractured massive carbide and associated matrix crack. Scanning electron micrograph. 1187× (b) Cross section through a cracked region in a similar part showing brittle fracture in the carbides More
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Published: 30 August 2021
Fig. 1 Timeline of medical device milestones (top) and United States Food and Drug Administration (FDA) medical device regulation (bottom) More
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Published: 15 January 2021
Fig. 9 Fracture in a thin medical device manufactured from type D2 tool steel. (a) View showing a fractured massive carbide and associated matrix crack. Scanning electron micrograph. Original magnification: 1187×. (b) Cross section through a cracked region in a similar part showing brittle More
Image
Published: 15 January 2021
Fig. 8 Fatigue fracture in a grade 2 titanium medical device. (a) Typical secondary electron image. (b) Additional surface detail in a reflected backscattered electron image obtained with the bias disabled on the secondary electron collector More
Series: ASM Failure Analysis Case Histories
Volume: 1
Publisher: ASM International
Published: 01 December 1992
DOI: 10.31399/asm.fach.v01.c9001133
EISBN: 978-1-62708-214-3
... manufacturing company. Both the sintered coating and the substrate were manufactured from cobalt-chromium-molybdenum alloy. Pertinent Specifications Medical prostheses used to replace joints in the human body are frequently manufactured as cobalt-chromium-molybdenum alloy investment castings...
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
... 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, postoperative...
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...
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Published: 30 August 2021
Fig. 2 So-called “three-legged stool” illustrating the contributions of device manufacturing/design, patient factors, and surgical factors to the success or failure of a medical device More
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Published: 01 January 2002
Fig. 39 Crystallographic fatigue in fracture mechanics specimen of cast Co-Cr-Mo-C medical implant alloy. SEM views located (a) 0.025 mm (0.001 in.) from machined notch tip, and (b) 7.6 mm (0.3 in.) from notch tip. Fatigue striations were not resolvable at any location, and the entire fatigue More
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Published: 15 January 2021
Fig. 39 Crystallographic fatigue in fracture mechanics specimen of cast Co-Cr-Mo-C medical implant alloy. Scanning electron microscope views located (a) 0.025 mm (0.001 in.) from machined notch tip and (b) 7.6 mm (0.3 in.) from notch tip. Fatigue striations were not resolvable at any location More
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
... procedures. Given the extreme conditions to which surgical tools can be exposed, and the potential for misuse, failures are inevitable and systematic methods for analyzing them are necessary to keep them in check. medical instruments fracture hydrogen embrittlement stainless steel corrosion pits...
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
.... 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 Introduction...
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
... were investigated: four nipple piercings (Jewelry 1 to 4, Fig. 1 a and b) and two navel piercings (Jewelry 5 and 6, Fig. 1c ). The medical history of each patient was not made available for this investigation. The surfaces of the samples were investigated by JEOL 6300 scanning electron microscopy...
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 Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006836
EISBN: 978-1-62708-329-4
... from a shape memory alloy can be used in medical treatments as they can be designed to be inserted into the body and then expand on reaching body temperature. These applications can result in unique spring failures. Example 15: Nitinol Orthodontic Archwires Investigation The fracture...
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