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Catalog Number 530.710 |
Device Problems
Detachment of Device or Device Component (2907); 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: the actual device was returned for evaluation.Quality engineering evaluated the battery oscillator device and the reported condition that the device was not working was confirmed.The device was visually inspected as received and it was found that the turn knob was loose.The cause for the loose turn knob is a confirmed design error and is covered under a capa in our quality system.A review of the device history was performed and no non-conformances were detected related to the reported condition.Udi - (b)(4).
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Event Description
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It was reported from singapore that during service and evaluation, it was determined that the locking knob of the battery oscillator device was loose.It was further determined that the device failed pretest for visual inspection, general condition, check the quick coupling for saw blades, check function of device, and check oscillation frequency with frequency meter.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 not reported, 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 will be submitted accordingly.
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Search Alerts/Recalls
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