Two guide wire grippers were sent in with this complaint for evaluation.Visual exams and functional tests were performed on both products.Manufacturing records and a technical evaluation showed the guide wire grippers were conforming to the specifications and material information sheet (mis).Both returned products show repeated use indicated by worn etching, dents and scratches, thread damage in one instrument, and guide wire hole damage in the other.The instruments had a potential field age of approximately 3.5 years at the time of incident with unknown usage history.This device is used for treatment.A functionality test was run on both products and one lot passed and the other lot failed, with use of a 3.0mm by 70cm guide wire.The failed product from the listed lot number is the part that exhibits hole elongation on both the top strike handle and the pivot plate.Based on information provided, the device has reached the end of its useful life.This issue has been investigated due to previous reports of this nature.A new design was released to increase the hardness of the strike plate and tighten the tolerance of the guide wire holes, which will improve gripping strength as well as durability.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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