The returned product was confirmed to have wear that could potentially cause loss of function.As returned, the guide wire grippers exhibited wear and tear that indicates use.A functional test was performed using smooth guide wires.The device functioned as intended while using the first tested feature.The second tested feature did not grip and hold the guide wire.Dimensional measurements and material hardness are conforming to print specification.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.The guide wire grippers had potential field ages of approximately 1 years and 2.5 years at the time of the reported incident.This device was used for treatment.Initial product history search conducted on august 30, 2016 revealed no additional complaints against the related part and lot combinations.The package insert included with the instrument has instructions for use, warnings, and precautions for the instrument.Some of these instructions are ¿end of life is normally determined by wear and damage due to use.Do not use cutting/sharp instruments with dull or deformed edges or instruments/provisionals that are deformed, corroded, damaged or worn.They may not perform as intended.If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.¿ the most likely cause of the instruments not gripping is wear and tear from use.
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