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Model Number EMAX2PLUS |
Device Problems
Material Frayed (1262); Vibration (1674)
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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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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 device experiencing vibration identified during service and evaluation was confirmed.The assignable root cause was determined to be due 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 experienced vibration, was loose and made an excessive noise.It was further observed that the device had component, flex circuit and cord damage.It was determined that the labeling had an illegible etch.It was noted that there was a hole in the hose, the connector was loose, and the device had a leakage.It was further determined that the device failed pretest for visual assessments, no short circuit between sensor gnd and connector body and noise assessment.It was noted in the service order that the device had hose damage.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 unknown.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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Search Alerts/Recalls
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