If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices were received and evaluated.Visual observation confirms that the sleeves and trocars are welded together.It was observed that the outer surface of the sleeves had striations on it indicating that it was loosely fit inside the guide frame.Historically, there are a couple of known factors that have been observed which could have caused or contributed to this type failure mode: if the pins on the trocar are not fully seated in the sleeve prior to the rotation of the trocar.If there is pressure applied to the side of the system (not drilling in line), and another factor is if the frame is out of straightness.All of these factors will cause the frame to bind with the sleeve/trocar resulting in welding of the two parts.This failure can be attributed to user technique.A dhr 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 synthes mitek complaints system revealed no other similar complaint 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.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 4 for the same event.It was reported by the sales rep that the customer's rigidfix femoral 3.3mm st cross pin kit, rigidfix femoral st guide frame, rigidfix femoral/tibial rod thumb screw failed during an anterior cruciate ligament acl reconstruction surgical procedure.It was reported that the surgeon placed the guide frame in and they binded up then cold welded but was unable to take apart.The surgeon stated that all of the devices looked too big and not working correctly.The case was completed with another like device.There were no adverse patient consequences or time delay.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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