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Model Number EMAX2PLUS |
Device Problems
Material Frayed (1262); Vibration (1674); 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 01/01/2023 |
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 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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had a hole in the hose, vibration, and 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 component failure due to wear.Udi ¿ (b)(4).
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Event Description
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It was reported from japan that during service and evaluation, it was determined that the motor device had a hole in the hose, cord damage, the connector was loose, the housing pin was loose, the set screw was loose, the device runs in the locked position, safe rotation, was making excessive noise, had vibration, and the etching was illegible.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 hose was damaged.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 2023.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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