(b)(4).Investigation summary: the device was received and evaluated at the service center.Neither the fault reported by the customer that the device had a short circuit could be verified nor another fault was found upon evaluation.The device was tested and found to be fully functional.Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined.No manufacturing record evaluation is required as no manufacturer or service related issues were found with the device.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
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