If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The lot number is currently unavailable; therefore, the exp date is unavailable.The complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event; 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.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 a meniscal repair surgical procedure, it was observed that the customer's omnispan meniscal gun jammed when deploying the 2nd implant of the omnispan meniscal repair system 12 degree.The surgeon cut the suture and left the 1st implant secured within the meniscus.The surgeon completed the procedure by free stitch with no patient consequences.There was a five minute delay reported.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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