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Catalog Number 530.705 |
Device Problems
Energy Output Problem (1431); Output below Specifications (3004); Complete Loss of Power (4015); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported from thailand that the battery oscillator device was powerless and did not have enough energy to cut the bone.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays to the surgical procedure.It was unknown if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2022.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: 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 from thailand that the battery reamer device was powerless and did not have enough energy to cut the bone.According to the reporter after being used for a while the device would heat up and would cool down after being turned off but after trying to cut again it would not cut the bone.It reported if the device was used in surgery, or if there was patient involvement.There were no delays to the surgical procedure.It was unknown if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2022.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device would not run due to a damaged electrical control unit.The reported condition of the device heating up was not confirmed.The assignable root cause was traced to component failure due to normal wear.
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Search Alerts/Recalls
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