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Catalog Number 530.710 |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Event Description
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It was reported from switzerland that during service and evaluation, it was determined that the knob on the battery oscillator device was damaged, the handpiece did not function at all, and the device failed the sticky trigger test.It was further determined that the device failed pretest for general condition, check the quick coupling for saw blades, check for sticky triggers, check the function of the device, and check oscillation frequency with frequency meter.It was noted in the service order that the locking knob was damaged.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 not reported, however, it was reported that the event occurred in 2023.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.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: the actual device was returned for evaluation.Quality engineering evaluated the battery oscillator device and the reported condition that the locking knob was damaged was confirmed.An assessment was performed, and it was determined that the device failed visual inspection because the knob was loose and the device failed the sticky trigger test.It was further determined that the device failed pretest for check for sticky triggers.The cause for the found defect of a loose knob is a confirmed design error and is covered under a capa.The assignable root cause of other failures was determined to be traced to component failure due to wear.A review of the service history record indicates that the device has not been serviced for a service condition that is not relevant to the current reported condition.Udi - (b)(4).
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Search Alerts/Recalls
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