Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not turn and had jammed motor and cracked cable.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: the cable was damaged.The values of the keypad were out of range.The motor was corroded and not running constantly.The motor, button and cable was defective.The motor, motor cable and hand control set were replaced 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 customer in (b)(6) that preoperatively to an unknown procedure on an unknown date, it was observed that the handpiece device did not turn as it had a jammed motor.During in-house engineering evaluation, it was determined that the motor was corroded and not running constantly.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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