The sales rep reported that during an acl repair the two of his omnispan meniscal appliers and two of his omnisplan meniscal repair systems, 12 degree needles would not deploy the 2nd implant.The sales rep reported that while deploying the 2nd backstop the spring went under the 2nd backstop and jammed the device.This was repeated with the 2nd applier and implant.The surgeon completed the procedure by removed the meniscus and moving on with no patient consequences.There was a 30 minute delay in the procedure.See associated medwatch 1221934-2014-00523, 1221934-2014-00524, 1221934-2014-00526.
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The complaint device was not returned to mitek and therefore a physical evaluation cannot be performed and a specific failure of the device cannot be determined.A root cause for the device to have malfunctioned cannot be discerned.No further technique or device details were provided to determine the root cause of the failure.A batch record review has been conducted and the 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 no other complaints for this lot of devices that were released to distribution.Based on the complaint history for this type of failure and patient harm, at this point in time, 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.
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