(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: despite multiple attempts made to the affiliate for the return of the complaint device, the device has not been received for evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part number, serial number combination.Review conducted per qlik query executed on 7/9/2019.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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).
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