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Catalog Number 530.710 |
Device Problems
Unintended System Motion (1430); Vibration (1674)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Event Description
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It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device could not be turned off and was jumping.It was reported that there were no delays in the surgical procedure.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 report 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.The battery oscillator device was evaluated and the reported condition that the device could not turn off and was jumping was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device would not run, had fluid ingress, corrosion/rusting/pitting, and a sticky trigger.It was further determined that the device failed pretest for general condition, check for sticky trigger, check the function of the device, and check oscillation frequency with frequency meter.The assignable root cause of these conditions was determined to be traced to the user, which is user error.
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Search Alerts/Recalls
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