If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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.A non-conformance search was performed for this product code 228141, lot 3882291 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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This is report 1 of 2 for the same event.It was reported by the sales rep that during an anterior cruciate ligament reconstruction acl/meniscus repair surgical procedure, it was observed that the second anchor would start to deploy when using the customer's ominspan meniscal repair 12 degree and the customer's meniscal deployment gun before the first implant would deploy.The sales rep reported that the surgeon completed the procedure with other likes devices with no patient consequences but there was a five minute delay.The sales rep stated that they are unsure if the gun is at fault or the implants.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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