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Catalog Number EMAX2PLUS |
Device Problems
Unintended System Motion (1430); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported by the netherlands that during service and evaluation, it was determined that the motor device was loose, cracked, locking components were damaged, produced excessive noise, had unintended activation/motion, illegible labeling etch, breaded stainless steel wire tether damage/came off, component damage and cord damage.It was further determined that the device failed pretest for visual assessment, cable assessment, safety assessment, noise assessment and air pump assessment.It was noted in the service order that the device did not work.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.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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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, it was determined that the reported condition that the device did not work was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had unintended activation/motion.The assignable root cause was determined to be due to component failure from wear.(b)(4).
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Search Alerts/Recalls
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