Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿
the complaint device was not received for evaluation.However, seven new unopened devices from the same lot were returned to mitek complaints for evaluation.Visually, there are no anomalies found on the devices.Four out of the seven devices were tested by mating with an expressew iii gun and tested on a sample rubber strip.All four needles were deployed successfully and suture passed through the rubber strip.This procedure was repeated several times successfully on each needle to confirm the suture passer performed as intended.We cannot confirm the reported failure of this device at this point.We cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution.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).Associated medwatches: 1221934-2018-50153 and 1221934-2018-50157.
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