(b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device was damaged was confirmed.The following defects were found with the device upon evaluation : outer tube damaged, needle outer tube dent(s).Outer tube damaged - distal tip damaged, shaver damage to distal tip, holes in distal tip fiber, fibers sunken in.Illumination - distal tip fiber damaged.Optical system - optical components broken lenses in optical system.The device was diagnosed and repaired with spare parts, tested and found to be fully functional.User mishandling is the most probable root cause of the physical damage to the device, including the broken lenses, probably due to fall.The damage to the distal tip is a result of contact with the shaver during a surgical process, as identified during evaluation.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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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