If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable; therefore, the exp date is unavailable.The complaint device was received and evaluated.The needle was stuck onto the end of omnispan gun.The silicon sleeve was not attached on the needle.The needle was removed from the end of the applier and the applier was tested and functioned as intended.This failure could have been caused if the user over-penetrated the needle during usage.When the needle is over-penetrated, result in a lot of needle length behind the meniscus, the silicone and implants can get ¿bound up¿, the implants may be shifted out of place, and silicone can develop prominent ridges that can catch on tissue and fat pad ¿ all of which could lead to difficulty in deployment.It cannot be determined at what point in time this failure occurred.This complaint can be confirmed.A batch review was not conducted for the needle as the batch number is unknown.However, depuy synthes mitek will continue to track any related complaints for this needle within this device family as a means of monitoring the extent with which this complaint is observed in the field.A review into the depuy synthes mitek complaints system for the omnispan gun revealed no other complaints of any kind for this lot of devices that were released to distribution.Therefore, at this point in time, based on the overall complaint rate for this failure mode, no further action is warranted.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 etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
|
This is report 2 of 2 for the same event.It was reported by the sales rep that during an anterior cruciate ligament repair surgical procedure, it was observed that the customer's omnispan meniscal applier would not fire.The sales rep reported that the triggers would not squeeze or move.The surgeon completed the procedure with another like device with no patient consequences or delays.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.
|