It was reported that during service and evaluation, it was determined that the robotic assisted satellite station device had two pushed in connector pins and the led on the robot showed green when the rest of the led's were orange.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).Investigation summary: evaluation of the returned device found that the satellite cable connector that connects to the main console was found to have 2 pushed-in pins.Also, the robot was identified to have electrical issues due to which the led on robot shows green when the rest of the leds on the robot is orange.Therefore, the reported issue could be confirmed.The assignable root cause was determined to be due to premature wear.
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