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Model 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 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 had vibration and the power cord was damaged.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 (b)(6) that during service and evaluation, it was determined that the motor device had cord damage, was making an unusual/excessive noise, the swivel turns once, the etching was illegible, the housing pin was loose, there was vibration present, and an air leak.It was further determined that the device failed pretest for visual assessment, loctite assessment, noise assessment, and air pump assessment.It was noted in the service order that the device had a damaged hose.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.Device evaluation update: upon further evaluation, it was found that an additional failure was observed.It was noted that the motor device had component damage.The assignable root cause of this condition was determined to be traced to component failure due to normal wear (faulty parts).This information does not change the reportability of the complaint and will remain a reportable malfunction.
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Search Alerts/Recalls
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