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Model Number EMAX2PLUS |
Device Problems
Appropriate Term/Code Not Available (3191); 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 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported from germany that during service and evaluation, it was determined that the motor device could not secure/lock the cutter, and the device would run in the locked position.It was further determined that the device failed pretest for cutter lock assessment 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.The exact date of the event was not reported, however, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become 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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device would run in the locked position.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.Udi ¿ (b)(4).
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Search Alerts/Recalls
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