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Catalog Number EMAX2PLUS |
Device Problem
Material Frayed (1262)
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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.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 device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to normal 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 cord was damaged, had cosmetic damage, loose, the bearing was worn, made excessive noise, was vibrating and the etching was illegible.During further investigation it was noted that the hose was damaged, had no red dot, the connector, housing pin and set screw were loose, air cooling ng due to damaged hose, abnormal noise and vibrated.It was further determined that the device failed pretests for visual assessment, loctite assessment, noise assessment and air pump assessment.It was noted in the service order that the device cord 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 date of event was unknown but was known to have 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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