If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record 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 internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed a similar complaint for this lot 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.However, depuy 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).This report is being filed from the remetrex 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 2 of 2 for the same event.It was reported by the hospital that during meniscal repair, it was observed that the second implant would not fire when it was intended to.According to the report, the event occurred when the surgeon went into the knee joint.It was reported that the implant was applied to the deployment gun and the surgeon was able to fire the first implant.The surgeon then pulled the first implant out and had the nurse open a new gun and needle.He repeated the process and it worked perfect.It was reported that it was like the needle was stuck on the first implant opened.It was not reported if there were any delays in the surgical 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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