The device was returned for evaluation.The reported condition was confirmed.Visual inspection of the product concluded dents are visible on the top and bottom surfaces of the gripper, indicating previous use.Damage was also noted to the threads and wear and elongation was evident on the 3mm hole.Manufacturing records for this lot were reviewed and did not indicate any manufacturing anomalies.The guide wire grippers were dimensionally analyzed and found to be within specification where measured.The device was used for treatment.The cause of the complaint was likely due to the wear and elongation of the 3.0mm hole in the pivot plate caused by normal use of the device over an extended amount of time.The gripper has a potential field age of over 4.5 years with an unknown number of uses.This product will be monitored for any adverse complaint trends.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
|