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Catalog Number EMAX2PLUS |
Device Problem
Fail-Safe Problem (2936)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported by netherlands that during service and evaluation, it was determined that the motor device ran in locked position.It was further observed that the device had e2 error code and damaged locking components.It was determined that the device¿s braded stainless steel wire tether was damaged came off.It was further determined that the device failed pretest for cable assessment and safety assessment.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 2024.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: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of the device ran in locked position identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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