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Catalog Number EMAX2PLUS |
Device Problems
Device-Device Incompatibility (2919); Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Event Description
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It was reported by china that during service and evaluation, it was determined that the motor device ran in a locked position, could not secure/lock cutter and displayed an e2(handpiece lock engaged) error code.It was further determined that the device failed pretest for cutter lock assessment and safety assessment.It was noted in the service order that during pre-surgery, it was discovered that the device had a lock issue and could not lock the consumable device.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.A spare device was available for use.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 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, an evaluation was performed, and it was determined that the reported condition that the device ran in a locked position was confirmed.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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