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Catalog Number EMAX2PLUS |
Device Problems
Unintended System Motion (1430); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2023 |
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device locking mechanism was stiff/stuck and the device had unintended activation/motion.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi (b)(4).
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Event Description
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It was reported from china that during service and evaluation, it was determined that the motor device locking mechanism was stiff/stuck and the device had unintended activation/motion.It was further determined that the device failed pretest for cutter lock assessment and safety assessment.It was noted in the service order that before an unknown surgery, the device had lock issue, and could not lock the consumable device.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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