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Catalog Number 05.001.201 |
Device Problems
Unintended System Motion (1430); Complete Loss of Power (4015)
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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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the device did not work was not confirmed.Therefore, an assignable root cause for the reported condition of will not run was not determined.However, during evaluation, it was determined that the device had unintended activation/motion.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 chile that during service and evaluation, it was determined that the battery handpiece device had corrosion/rusting/pitting, unintended activation/motion and component damage.It was further determined that the device failed pretest for check function of device, check for unintended motion, check in ¿off/lock¿ mode, check function of all possible modes with power module and lid and check the incompatibility with lid of trs recon saw.It was noted in the service order that the device did not work.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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Search Alerts/Recalls
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