(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: the device was sent to the service center for evaluation.Defects were found with the complaint device; this complaint is confirmed.The following defects were found at the service center and have been repaired.Motor does not turn: motor replaced.Short circuit in the motor cable - motor cable replaced.Resistance value out of specs: handcontrol set replaced.The root cause for the device failure is a defective motor, a short circuit in the motor cable, and resistance values of the keypad were out of specification.The complaint device has been repaired, tested, and found to be fully functional.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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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