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Catalog Number 530.705 |
Device Problems
Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device was not working was not confirmed.Therefore, the assignable root cause was not determined.However, the malfunctions found during service and evaluation have been confirmed.The assignable root cause was determined to be due to user error.(b)(4).
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Event Description
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It was reported from netherlands that during service and evaluation, it was determined that the battery reamer device had sticky trigger.It was further determined that the device failed pretest for check for sticky trigger.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 2024.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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