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Catalog Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Unintended System Motion (1430); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device having an unintended activation/motion and displaying an e6 error code indicating handpiece overheat warning, identified during service and evaluation were confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.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 had an unintended activation/motion and displayed an e6 error code indicating handpiece overheat warning.It was further observed that the locking components and flex circuit were damaged.It was further determined that the device failed pretest for no short circuit between phases and connector body, no short circuit between hall sensors and connector body, no short circuit between 5vdc line and connector body, no short circuit between sensor gnd and connector body and safety assessment.It was noted in the service order that the device had an undetermined malfunction.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, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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