The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The instructions for use (ifu) sent with this device, states the following; · end of life is generally determined by wear and damage due to intended use.· visually inspect for damage and wear.· check hinged instruments for smooth movement.· discard damaged instruments.· viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures.· do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion.· manual surgical instruments have a limited lifespan which is generally determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The device history records (dhr) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device had experienced approximately 2.32 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly and a supplemental medwatch 3500a emdr will be submitted as well.No further investigation is required at this time.H3: updated to state device not returned to manufacturer.H6: updated investigation findings and conclusions.
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