This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.The returned product was confirmed to have wear that could potentially cause loss of function.As returned, the guide wire gripper exhibited wear and tear that indicates use.A functional test was performed using 2.4mm and a 3.0mm smooth guide wires.The device functioned as intended while using the 2.4mm feature.The 3.0mm feature did not grip and hold the 3.0mm guide wire.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.The guide wire gripper had a potential field age of approximately 1.5 years at the time of the reported incident.This device is used for treatment.Initial product history search conducted revealed no additional complaints against the related part and lot combination.Per the package insert for the instrument, ¿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.
|