The perforator was returned for evaluation.Failure analysis: the perforator unit was inspected using the unaided eye.The unit had to be disassembled because the inner drill was fused to the outer drill.There were visible tool marks on the outside.Instructions for use testing procedure was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A trending and risk assessment were performed as part of the evaluation.Product was received for analysis and the investigation could not confirm the complaint.
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