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Catalog Number EMAX2PLUS |
Device Problems
Complete Loss of Power (4015); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device could not secure the cutter device, heated up, had low power, component damage, the speed could not be changed and run in the locked position.The device also failed pretests for cutter lock assessment, motor thermistor assessment, safety assessment, rotational speed assessments, noise assessment, handpiece temperature assessment and hand control assessment.The assignable root cause was traced to improper maintenance.Udi: (b)(4).
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Event Description
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It was reported from india that during service and evaluation, it was determined that the motor device could not secure the cutter device, heated up, had low power, component damage, the speed could not be changed and run in the locked position.It was further determined that the device failed pretests for cutter lock assessment, motor thermistor assessment, safety assessment, rotational speed assessments, noise assessment, handpiece temperature assessment and hand control assessment.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2024.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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