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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.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
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
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c9001690
EISBN: 978-1-62708-226-6
... established as a consequence of the failure of medical implants in service. 6 The present U.S. legislation governing failure of medical devices is rigorous with respect to liability of the manufacturer. The manufacturers are considered legally responsible for the performance of the products and are often...
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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
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
... and whether or not the tool is meant to be re-used. As with most medical devices, there are tradeoffs for surgical tools between performance and expected lifetimes. For instance, the intended use condition for a hip implant broach handle involves striking the instrument with a hammer. In this case...
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
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 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
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.homegoods.c9001610
EISBN: 978-1-62708-222-8
... conditions (passivation and surface roughness). Review of ASTM medical device standards, 8 however, does not provide any quantitative data concerning surface roughness and finish of surgical implants. One standard, 9 concerning the practice for surface preparation of metallic surgical implants, states...
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
.... 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. Biomaterials Biomechanics Fatigue crack growth Medical device 300 series Fatigue fracture The use...
Series: ASM Handbook
Volume: 11B
Publisher: ASM International
Published: 15 May 2022
DOI: 10.31399/asm.hb.v11B.a0006938
EISBN: 978-1-62708-395-9
... interactions may take on a special meaning for particular classes of polymeric parts such as implantable medical devices, which are subject to particular design controls and associated regulatory requirements. The conditions experienced by such devices initially involve surgeon handling and placement, which...
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
... in medical devices and surgical implants. Example 16: Ultrasonic Cleaning-Induced Failures in Medical Devices Investigation A nitinol stent subjected to an unintentionally long ultrasonic cleaning treatment fractured during bend testing ( Ref 11 ). SEM analysis showed that striations were present...
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
... on the secondary electron detector can also be varied on some instruments to obtain a highly directional BSE image (sometimes referred to as a reflected electron image). Figure 8 shows a fracture surface for a titanium alloy implantable medical device where the fracture radial ridges that mark a fracture origin...
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
Series: ASM Failure Analysis Case Histories
Publisher: ASM International
Published: 01 June 2019
DOI: 10.31399/asm.fach.med.c0047158
EISBN: 978-1-62708-226-6