Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.Visual observations revealed that the right side of the upper jaw hook was bent inwards.This type of failure could be attributed to blunt force impact; potential root causes include the device hitting bone during a procedure or the device being mishandled.When attempting to load a test needle in the needle tray, the needle could not fully be seated, there could be a blockage preventing the needle to fully enter the needle tray, confirming this complaint.Via functional test, when the trigger was actuated, the jaws did not function properly.The jaws did close or open successfully, however the jaw to shaft pin was intact.There two possible root causes for this type of functional failure: there is excess surgical debris jammed in the gun, or since the upper jaw was bent from blunt force impact there is a possibility that the internal mechanism of the jaw was damaged.Other than the possible root causes listed a specific root cause couldn¿t be determined at this time.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 related complaint search in depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that was released to distribution.And at this 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.(b)(4).
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