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Catalog Number 530.710 |
Device Problems
Device Slipped (1584); Vibration (1674); 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 04/07/2023 |
Event Type
malfunction
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Event Description
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It was reported from japan that during an unspecified surgical procedure it was observed that when the battery oscillator device was being used it had vibration.It was reported that the vibration caused the locking knob to turn and the blade lock to disengage.It was reported that the locking knob was fixed using oif tape and the device was used continuously.It was reported that there was no delay in the procedure due to the event.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.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: e1: reporter's phone number was not provided.D4: udi: lot/serial unknown.(b)(4).H4 device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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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 had vibration causing the locking knob to turn and the blade lock to disengage was confirmed.The device was visually inspected as received and it was found that the device failed the visual inspection due to being received with a detached turn knob.The device was fully functioning and reached the required speed requirements.It was further determined that the device failed pretest for general condition and check the quick coupling for saw blades.It was determined that the most relevant root cause could be linked to a design error.Further investigation and assessment are covered under a capa.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.
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Search Alerts/Recalls
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