Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that bent scope.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit.Distal tip damaged.Objective damaged window damaged.Optics are damaged.Image is cloudy/foggy.The objective and objective window were replaced, internal scope cleaning and laser weld eyepiece as originally designed to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.
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It was reported by the sales rep that during a shoulder repair procedure on (b)(6) 2021, it was observed that the scope on the arthsco,4/140_30_qik/strkr hub device was bent.During in-house engineering evaluation, it was determined that the image on the device was cloudy/foggy.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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