If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.The complaint device is not being returned, therefore unavailable for a physical evaluation.Historically, this type of failure has been attributed to user technique issue.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.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were 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.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 (b)(4) 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 affiliate in (b)(6) that during a left anterior cruciate ligament acl reconstruction soft tissue surgical procedure, during use of the 'rigidfix soft tissue guide' instrument to place the single use trocars from a 'rigidfix femoral st cross pin kit' via drill power, it was observed that the guide and trocar have cold welded together.The surgeon was unable to advance the trocar into the appropriate position.There was no harm caused to the patient.There was visual damage noted to the instrument and trocar.The guide and trocar were removed and a second 'rigidfix soft tissue guide' instrument and 'rigidfix femoral st cross pin kit' were opened and used successfully to complete the case.There was a delay in the surgical procedure of 10 minutes.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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