Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was not returned by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported by the affiliate that the patient experienced an allergic reaction with the pin from the rigidfix kit.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part 210133 lot l689884 combination and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.Udi: (b)(4).
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