Udi: (b)(4).Investigation summary : the complaint device was received at the service center and evaluated.It was reported that does not work on, cracked cable.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor was corroded and does not run.Further, the button was not functioning, and cable was damaged.Also, found that the values of the keypad were out of range.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.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.Corroded motor has a tendency to stick and not turn.Further, user mishandling might be the most probable root cause for the damaged cable.Additionally, when the resistance values of the keypad are out of range, the keypad of the device may not respond, therefore is a potential root cause which could impact the functionality of the device causing it not to function as intended.However, we cannot determine what caused the out of tolerance failure.A manufacturing record evaluation was performed for the finished device serial number ((b)(4)), and no non-conformance was identified.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 in (b)(6) that during an unknown surgery on an unknown date, it was observed that the micro tornado hp w handcontrol device did not work and had a cracked cable.During in-house engineering evaluation, it was determined that the motor was corroded and did not run.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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