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Catalog Number EMAX2PLUS |
Device Problems
Fail-Safe Problem (2936); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that the motor device was broken.During an in-house engineering evaluation, it was determined that the device had an e6 error code, foreign substance/debris/cleaning/sterilization and ran in the locked position.It was also found that the device failed pre-test for safety (cutter did not rotate e2 displayed).It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.(b)(4).
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Search Alerts/Recalls
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