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Model Number EMAX2PLUS |
Device Problems
Break (1069); 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 11/25/2022 |
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 reported condition of the bearing being damaged was not confirmed.Therefore, an assignable root cause was not determined.However, the device running in locked position identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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Event Description
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It was reported by china that during service and evaluation, it was determined that the motor device ran in locked position.It was determined that the device was missing components, and it displayed an e8 error code indicating system fault.It was observed that the labeling had an illegible etch.It was further determined that the device failed pretest for visual assessment and safety assessment.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the bearing was damaged.It was not reported if there were any delays in the surgical procedure.It was reported that a spare device was used to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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