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, or its employees that the report constitutes an admission that the product, depuy synthes, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.D10: concomitant med products and therapy dates: console device, (b)(6) 2023.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device displaying an e8 error code on the console indicating system fault was not confirmed.Therefore, an assignable root cause was not determined.However, the device leaking liquid and running in locked position, identified during service and evaluation were confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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It was reported by switzerland that during service and evaluation, it was determined that the motor device ran in locked position and leaked liquid.It was further observed that the device displayed an e2 error code indicating handpiece lock engaged.It was further determined that the device failed pretest for loctite assessment and safety assessment.It was noted in the service order that the device displayed an e8 error code on the console device indicating system fault.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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