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 damage or premature failure. Several cases of ultrasonic cleaning-induced fatigue and corresponding failures of medical devices are examined in this review. Preventative measures to ensure that ultrasonic cleaning frequencies do not pose a threat are also provided.

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.

Electroless nickel plating separation from copper alloy CDA175 retaining clips used on printed circuit boards was caused by a copper oxide layer that reduced adhesion of the nickel plating on the clips. Stresses that developed during module insertion caused flaking to occur at the oxidized copper surface. Electroless nickel plating separation from OFHC copper leads was caused by improper handling rather than a plating anomaly per se. Tin plating separation from copper underplating on a hybrid package lid occurred because of a four-week delay between the copper plating and tin plating steps. It was recommended that tin plating should follow the copper underplating within 24 h and a cleaning step of bright dipping after copper plating be performed.

Problems with materials compatibility were encountered in pyrotechnically driven devices used in a number of ordnance applications requiring rapid mechanical actuation. A fine bridgewire is located in contact with the chemical pyrotechnic, and the charge is ignited by electrical heating of the bridgewire. Evidence of severe corrosion was revealed on examination of the nickel-chromium-iron alloy bridgewire and the nickel-iron alloy pins. Metallic elements in the pin or bridgewire and substantial amounts of chlorine were detected from the x-ray spectra. Morphological changes indicative of decomposition and dissolution were revealed to have occurred in regions of the pyrotechnic that had been in contact with the bridgewire and pin surfaces by examination of the titanium-potassium perchlorate (Ti-K-Cl-O4) pyrotechnic. Substantial amounts of water were revealed to be associated with the surfaces of the titanium particles in the pyrotechnic by nuclear magnetic resonance. It was proposed that the chlorine-containing residue combined with the water from the pyrotechnic to form a thin aqueous film corroding the bridgewire and pins. A new cleaning procedure was implemented for the glass headers to eliminate the chloride contamination and a vacuum drying procedure was instituted for the pyrotechnic.

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.

An ASTM A391 steel chain link of an over head hoist failed catastrophically, causing damage to both property and personnel. Macrofractography identified the sequence of fractures within the chain link. The first fracture occurred at the welded joint, a second occurred opposite the weld. SEM fractography and metallography indicated that the link failed in a ductile manner because of tensile overload, which occurred when the hoist hook contacted the hoist's housing and prevented uptake of the chain. It was recommended that a load-sensing device be installed to prevent future occurrences and that a dye penetrant inspection be performed on the renwinder of the chain.

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.

A failure analysis was conducted on a flow-sensing device that had cracked while in service. The polysulfone sensor body cracked radially, adjacent to a molded-in steel insert. This article describes the investigative methods used to conduct the failure analysis. The techniques utilized included scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, thermomechanical analysis, and melt flow rate determination. It was the conclusion of the investigation that the part failed via brittle fracture, with evidence also 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 in coefficients of thermal expansion between the polysulfone and the mating steel insert.

Total knee prostheses were retrieved from patients after radiographs revealed fracture of the Ti-6A1-4 VELI metal backing of the polyethylene tibial component. The components were analyzed using scanning electron microscopy. Porous coated and uncoated tibial trays were found to have failed by fatigue. Implants with porous coatings showed significant loss of the bead coating and subsequent migration of the beads to the articulating surface between the polyethylene tibial component and the femoral component, resulting in significant third-body wear and degradation of the polyethylene. The sintered porous coating exhibited multiple regions where fatigue fracture of the neck region occurred, as well as indications that the sintering process did not fully incorporate the beads onto the substrate. Better process control during sintering and use of subsequent heat treatments to ensure a bimodal microstructure were recommended.

Several surface-mount chip resistor assemblies failed during monthly thermal shock testing and in the field. The resistor exhibited a failure mode characterized by a rise in resistance out of tolerance for the system. Representative samples from each step in the manufacturing process were selected for analysis, along with additional samples representing the various resistor failures. Visual examination revealed two different types of termination failures: total delamination and partial delamination. Electron probe microanalysis confirmed that the fracture occurred at the end of the termination. Transverse sections from each of the groups were examined metallographically. Consistent interfacial separation was noted. Fourier transform infrared and EDS analyses were also performed. It was concluded that low wraparound termination strength of the resistors had caused unacceptable increases in the resistance values, resulting in circuit nonperformance at inappropriate times. The low termination strength was attributed to deficient chip design for the intended materials and manufacturing process and exacerbated by the presence of polymeric contamination at the termination interface.

X-ray spectroscopy is generally accepted as the most useful ancillary technique that can be added to any scanning electron microscope (SEM), even to the point of being considered a necessity by most operators. While “stand-alone” x-ray detection systems are used less frequently in failure analysis than the more exact instrumentation employed in SEMs, the technology is advancing and is worthy of note due to its capability for nondestructive analysis and application in the field. This article begins with information on the basis of the x-ray signal. This is followed by information on the operating principles and applications of detectors for x-ray spectroscopy, namely energy-dispersive spectrometers, wavelength-dispersive spectrometers, and handheld x-ray fluorescence systems. The processes involved in x-ray analysis in the SEM and handheld x-ray fluorescence analysis are then covered. The article ends with a discussion on the applications of x-ray spectroscopy in failure analysis.

A gear belonging to a pressurized heavy-water reactor refueling machine failed after 10 years in service. The material specified for the gear was a type C90700 bronze. Macroscopic examination focused on three gear teeth that had fractured completely at the roots, and fracture zones were examined using SEM microscopy. Failure of the gears was attributed to heavy wear resulting from misalignment. A lack of adequate lubrication was also noted. Periodic alignment adjustment and lubrication were recommended.

This article covers the three most popular techniques used to characterize the very outermost layers of solid surfaces: Auger electron spectroscopy (AES), X-ray photoelectron spectroscopy (XPS), and time-of-flight secondary ion mass spectrometry (TOF-SIMS). Some of the more important attributes are listed for preliminary insight into the strengths and limitations of these techniques for chemical characterization of surfaces. The article describes the basic theory behind each of the different techniques, the types of data produced from each, and some typical applications. Also discussed are the different types of samples that can be analyzed and the special sample-handling procedures that must be implemented when preparing to do failure analysis using these surface-sensitive techniques. Data obtained from different material defects are presented for each of the techniques. The examples presented highlight the typical data sets and strengths of each technique.

This article provides information on the chemical characterization of surfaces by Auger electron spectroscopy (AES), X-ray photoelectron spectroscopy (XPS), and time-of-flight secondary ion mass spectrometry (TOF-SIMS). It describes the basic theory behind each of these techniques, the types of data produced from each, and some typical applications. The article explains the strengths of AES, XPS, and TOF-SIMS based on data obtained from the surface of a slightly corroded stainless steel sheet.

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.

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.