Perforator (id 261221) was returned for evaluation.Failure analysis - the perforator unit was inspected using the unaided eye: the unit was heavily soiled with organic material between the inner and outer drill and had a worn label.Instructions for use (ifu) testing procedure was performed after freeing the inner and outer drill by drilling test holes.The organic matter had to be freed before testing.Once freed, the unit passed the spring test as designed.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.It is suspected that the organic material caused some friction and difficulty at first, but as more organic material was freed, drilling was found to occur as expected.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Potential causes of failure include, user misuse.
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