(b)(4).Device was used for treatment, not diagnosis.Investigation summary: product was not returned and thus not available for physical evaluation.Hence, the reported complaint cannot be confirmed.Furthermore, no lot number was supplied which precludes conducting a device history record review or a lot specific search in the complaints handling system.No further information regarding this event has been provided to determine a root cause for this failure.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.(b)(4) -incomplete.Depuy synthes has been informed that the lot number is not available.
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