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Catalog Number 530.710 |
Device Problems
Mechanical Problem (1384); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/02/2023 |
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.The actual device was returned for evaluation.The battery oscillator device was evaluated and the reported condition that the saw lock did not work was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had intermittent operation.The assignable root cause was determined to be traced to the user, which is user error.Udi - (b)(4).
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Event Description
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It was reported from brazil that during service and evaluation, it was determined that the battery oscillator device had intermittent operation and component damage ¿ saw blade coupling thread.It was further determined that the device failed pretest for general condition, check the quick coupling for saw blades, check the function of the device, and check oscillation frequency with frequency meter.It was noted in the service order that the saw lock 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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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