(b)(4).Dents are visible on the top and bottom surfaces of the gripper indicating previous effective use.Abrasion was also visible on the 3.0mm holes in the handle and pivot plate.Damage was also noted to the threads.The guide wire grippers were dimensionally analyzed and found to be within specification where measured.This device was used for treatment.The damage on the locking teeth might have contributed to the gripping condition.Due to the damage on the teeth, the gripper was not able to lock at fully stretched condition.The probable cause for the elongation of hole feature is likely wear due to normal use and teeth damage might be due to wear and tear or excessive force applied on locking nut; however this cannot be confirmed with available information.The gripper has a potential field age of approximately 1.5 years with an unknown number of uses.The device has reached the end of its useful life.This failure mode has been identified as a reoccurring complaint.A new design was released to increase the hardness of the strike plate and tighten the tolerance of the guide wire hole.This will provide additional useful life from the device.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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