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Catalog Number 05.001.202 |
Device Problems
Unintended System Motion (1430); 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 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported from colombia that during service and evaluation, it was determined that the power module device warning light indicator came on, had unintended activation/motion, would not charge and had component damage.It was further determined that the device failed pretest for general condition and lever function, check charging sockets, information button and self test, charging and checking of the power module in charger, check for unintended motion with handpiece, check in off/lock mode with handpiece, function test, saw test and check liquid indicator.It was noted in the service order that the device service indicator light lit up.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, an additional report 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 user error.Udi:(b)(4).
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Search Alerts/Recalls
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