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Model Number EMAX2PLUS |
Device Problems
Material Frayed (1262); Unintended System Motion (1430); 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 01/01/2022 |
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, unintended activation/motion, and running in locked position, identified during service and evaluation were 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, unintended activation/motion, and the device ran in locked position.It was further observed that the device had a flex circuit, component, hose and cord damage, and the labeling had an illegible etch.It was determined that the housing pin, connector and set screw were loose, the device made an excessive noise, had missing components and a connector pin, and the speed could not controlled/changed.It was further noted that the device was rotating on safe, and the ¿hc¿ was not operating or cooling air due to hose damage.It was further determined that the device failed pretest for visual assessments, loctite assessments, safety assessment, noise assessment, air pump assessment and hand control 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 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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