If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint devices were not returned, therefore unavailable for a physical evaluation.A definitive root cause could not be determined at this time but it is possible that the sleeve was not fully retracted into the device, causing a loose connection.A dhr 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 internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed 1 dissimilar complaint this lot of devices that were released to distribution.At this point in time, 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported by the affiliate in (b)(6) that at the moment of meniscus suture of patient, the applicator caught, and lost the suture needle during an unspecified surgical procedure.It was not reported if there was a delay in the surgical procedure of if a spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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