If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the product cable was stripped.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: cable sheath cut.Keyboard resistance value out of tolerance limits.Corroded motor.The cable, keyboard and motor were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The improper maintenance 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 customer in france that during an unknown surgery on an unknown date, it was observed that the cable on the micro tornado hp w handcontrol device was stripped.During in-house engineering evaluation, it was determined that the device had corroded motor.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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