Orthopedic Implants and Surgical Device Failure Analysis - Over the past 20 years, Thielsch Engineering has performed numerous investigations of failures of various medical devices and implants subject to failure or requiring qualification and/or performance testing.

We can provide metallurgical and mechanical engineering evaluations and failure analyses of a broad range of products, equipment and components. This includes the design, use of materials and processing, clinical evaluations, manufacture, advertising claim reviews, product qualification testing and clinical use of medical implants and devices.

Thielsch Engineering has performed failure analyses on orthopedic implants, metallic and non-metallic surgical implements, coronary stents, sutures and suture anchors, angioplastic balloons, wound closure devices and hip implants as well as other medical products.

Thielsch Engineering is very familiar with the various types of stainless steels, nickel alloys, titanium alloys and engineering plastics that are utilized in medical devices, as well as many other metals, alloys and non-metallic materials utilized in various industrial applications.

Examples include:

• Mechanical testing and metallurgical evaluations of hypodermic needles, including the performance of finite element analyses and mechanical determinations of Young’s modulus and yield strength and tensile strength values

• Mechanical testing of surgical devices used to apply protective coatings to internal sutures

• Load-to-cut and high-cycle fatigue testing of various surgical instruments subject to possible conditions of overloading. Including testing of arthroscopic manual instruments used in knee surgeries

• Determinations of fretting corrosion damage on prototype hip implants

• Metallurgical, scanning electron microscope and x-ray diffraction evaluations and analyses of shape memory alloys used in arterial filters

• Scanning electron microscopy, energy-dispersive spectroscopy and related analyses of bound wire bundles utilized in medical implants

• Failure analyses of ultrasonic surgical instruments.

Call us to find out more about:

• ASTM and NACE Testing

• Cardiovascular Devices

• Component Design and Analysis

• Component Evaluation and Testing

• Corrosion Investigations

• Customized Materials and Component Testing

• Expert Witness in Implant and Device Failures

• Failure Analysis

• Fatigue Testing

• Litigation Support

• Materials Characterization

• Materials Development and Qualification

• Mechanical Testing

• Orthopedic Implants and Devices

• Performance Simulation Testing

• Strain Gauge Measurements of Stresses in Cardiac Surgical Instruments

• Reverse Engineering.

For more information contact:
Ara Nalbandian
Tel: (401) 467-6454
Fax: (401) 467-2398
E-mail: nalbandiana@thielsch.com

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