(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received at service center and evaluated.The customer reported an article defect, a plastic part was present in the head, therefore we can confirm this complaint as a defect was found with the complaint device.The unit has been checked for technical safety.No technical or functional faults were found in the functional tests carried out on the unit.However, given the information provided we cannot discern a definitive root cause for the identified failure.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 07/24/2018 and passed all functional testing before being returned to the customer.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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