(b)(4).Device analysis: visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.The remaining device characteristics show no anomalies for a device that has been reasonably changed as part of the explant procedure.Analysis found that the returned device had an exposed weld ball visible paired with the washer side of the adjacent bead.The washer through hole was measured with computed tomography (ct) and found to out of specification.The paired weld ball diameter was found to meet specifications.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.As the device was tested to 250g tensile force in production, it is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation in vivo.The dhr for lot 8775 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.
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