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Catalog Number 530.710 |
Device Problems
Device-Device Incompatibility (2919); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2023 |
Event Type
malfunction
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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 the thread saw blade coupling had component damage, operated intermittently and could not secure/lock cutter device.It was further determined that the device failed pretests for general condition, quick coupling for saw blades, function of device and oscillation frequency with frequency meter.It was noted in the service order that the lock on the device would not hold the blade during a surgical procedure.There was no surgery delay.There was patient involvement.There was no harm to the health of the operator or patient.All available information has been disclosed.If additional information should become 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 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 traced to user error.Udi: (b)(4).
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Search Alerts/Recalls
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