The complainant reported that the upper articulating arm of a pituitary rongeur came off during a procedure.The piece was retrieved with no complications or delay in treatment.There were no reported patient complications associated with this event.The complainant reported that the sets have been in use for at least two years, and that this size pituitary rongeur is used the most during the surgeon's procedures.A visual assessment of the complaint instrument identified that the bottom cutting surface of the pituitary rongeur was worn.The articulating arm that is intended to have the superior cutting surface present was fractured.The three spot welds intended to secure the pivot pin of the instrument/distal handle interface were broken and the pivot pin was shifted out of placement and protruding on one side.A functionality assessment could not be performed due to the broken condition of the instrument.If repeated excessive compression force was applied to the handles of the instrument, it could contribute to an instrument malfunction at the area where stress risers are present.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to initially being released to distributable inventory.This lot has been available for distribution since 2/03/2016.
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