Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at the service center and evaluated.On inspecting the device, deficiencies were found to be impairing device function and the reported complaint was confirmed.The housing was damaged.The insulation resistance of the motor was outside tolerance.It was also noted that the motor does not turn.There was a cut in the motor cable and there was a short circuit in the motor.Also the resistance values of the keypad of the handcontrol were out of specifications.It was also noted that the cupstyle washer was loose.The handle, motor, motor cable and the handcontrol set were replaced.The complaint device was cleaned, repaired and tested for functionality.Also preventive replacement of o-rings was performed.The housing damage is most likely caused by user mishandling.However, given the information provided we cannot discern a definitive root cause for the other identified failures.A manufacturing record evaluation was performed for the finished device [serial: (b)(4)] number, and no non-conformances were identified.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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