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Catalog Number 530.710 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2023 |
Event Type
malfunction
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Event Description
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It was reported by germany that during service and evaluation, it was determined that the battery oscillator device would not run due to electrical control unit damage and had moving parts that did not move smoothly-trigger.It was further determined that the device failed pretest for check for sticky trigger, check function of device and check oscillation frequency with frequency meter.It was noted in the service order that the device did not work properly.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 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.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 repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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