Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Visual inspection confirms that the needle shaft of the truespan broke off.Thus, confirming this complaint.The implants and suture were both intact within the needle confirming no implants were deployed in the joint.The pusher rod was evaluated, via functional testing the trigger was pulled.A click was heard as intended, indicating the functionality of the device is sound.While fully pulling the trigger to expose the pusher rod, visually the pusher rod looked to be deformed.It was reported that the patient had a small joint which could¿ve made a difficult entry for the user, resulting in the excessive force used on the truespan device to get access to the meniscus.Other than these possibilities listed, a specific root cause cannot be determined.The dhr review indicated that this batch of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices 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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