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Outsourced Component Did Not Contribute to Medical Device Implant Failure
When the manufacturer of a medical device implant saw an increase in the device’s failure rate after implant, they alleged that a component provided by a supplier was responsible.
The supplier of the component retained RJ Lee Group to characterize the physical, chemical and microstructural properties of the component – both as they supplied it to the manufacturer and again after the manufacturer applied a surface coating to it - to determine if specifications were met. RJ Lee Group experts also evaluated failed components after they were explanted from patients. We used optical microscopy, scanning electron microscopy and mechanical techniques to examine the failed components.
We also visited the supplier’s plant to review the machining process and studied documentation and data including specifications, inspection reports and studies that were conducted before placing the device in humans. We then provided testimony demonstrating that the increased failure rate of the device was not the result of the supplier’s process.