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Model Number EMAX2PLUS |
Device Problems
Vibration (1674); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2022 |
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.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: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of vibration identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).
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Event Description
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It was reported by japan that during service and evaluation, it was determined that the motor device had vibration.It was further observed that the device had cord damage, illegible etch, component damage, and excessive noise.It was determined that the device ran in locked position and was loose.It was further observed that moving parts of the device did not move smoothly.It was further determined that the device failed pretest for visual assessment, loctite assessment, safety assessment and noise assessment.It was noted in the service order that the device was difficult to disassemble.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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