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Catalog Number 530.710 |
Device Problems
Device Slipped (1584); Detachment of Device or Device Component (2907)
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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 has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi - (b)(4).
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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 locking knob of the battery oscillator device fell apart ¿ unattached.It was further determined that the device failed pretest for visual assessment, 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 from japan that the blade connecting part was loose.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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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.Quality engineering evaluated the battery oscillator device, and the reported condition blade connecting part was loose was confirmed.The device was visually inspected as received and it was found to have failed visual inspection, due to locking knob fell apart.An assessment was performed, and it was determined that the locking knob of the handpiece fell apart.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.The root 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 service history record indicates that the device has not been serviced for a service condition that is not relevant to the current reported condition.
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Search Alerts/Recalls
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