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Catalog Number 05.001.202 |
Device Problems
Leak/Splash (1354); Component Missing (2306)
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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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Event Description
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It was reported by japan that during service and evaluation, it was determined that the power module device leaked liquid, could not remove battery/power module/unit and had missing components-handle/lever.It was further determined that the device failed pretest for general condition & lever function, check device interaction ¿ power module to handpiece & lid and check liquid indicator.It was noted that device had a missing lever, was difficult to remove and had water leakage.It was noted in the service order that the device handle was missing.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 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 was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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