Device was used for treatment, not diagnosis.The complaint device was received and evaluated.Visual observation revealed the upper jaw on the expressew iii was significantly deformed and bent outward.This contributed to the misalignment of the jaws and the failure of the passer to perform as intended.The reported complaint was confirmed.Historically, there are two known root causes for the bent jaw.One possible root cause is that the end user might have hit hard bone in the joint space forcing the jaws of the device and suture track to bend.Another possible root cause is that this instrument was not properly handled during cleaning and sterilization resulting in impact damage to the distal tip of the device.Based upon the investigation the damage to the device (distal tip) was likely caused by improper handling.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one similar complaint for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
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