Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.The reported failure is confirmed, the sleeve and trocar are cold welded together.There are visible striation marks on the trocar.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these groves then the trocar is spinning within the guide sleeve causing enough heat and friction to cause the welding of the two parts.Therefore, this type of failure has been attributed to user technique issue.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and 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.Udi: (b)(4).
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