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Model Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to 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 a damaged flex circuit, leaked liquid, displayed an e6 (overheat warning) error code, would not run due to motor damage, had foreign substance/debris/cleaning/sterilization and cosmetic damage.It was further determined that the device failed pretest for motor thermistor assessment, 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 during during checks before surgery, it was discovered that the motor device did not work properly.It was not reported if there were any delays in the surgical procedure.A spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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