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Model Number EMAX2PLUS |
Device Problems
Material Frayed (1262); Unintended System Motion (1430); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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, 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.Additional narrative: 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 making an excessive noise was not confirmed.Therefore, an assignable root cause was not determined.However, the device experiencing an unintended activation/motion, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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Event Description
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It was reported by switzerland that during service and evaluation, it was determined that the motor device experienced an unintended activation/motion.It was further observed that the device had component damage, would not run due to a motor damage, and displayed an e8 error code indicating system fault.It was further determined that the device failed pretest for visual assessment, motor thermistor assessment and safety assessment.It was noted in the service order that the hose was broken on the device.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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Search Alerts/Recalls
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