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Catalog Number 530.710 |
Device Problems
Unintended System Motion (1430); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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It was reported from japan that during pre-surgery, it was discovered that the batter oscillator device did not work when the trigger was pressed.When the battery was pushed upward with hand, the device moved but did not move for long.It was further reported that the device stopped abruptly when the battery were replaced, and sometimes moved even when the trigger was not pressed.The device was used for surgery with the battery removed and re-attached just prior to each osteotomy timing.It was reported that there was a thirty-minute delay to the surgical procedure.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.H10 additional narrative: e1: the reporter¿s complete facility address was not provided.Device evaluation: 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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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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had cosmetic damage, corrosion/rusting/pitting and contact damage.It was further observed that the device would not run.It was further determined that the device failed pretest for general condition, check function of device and check oscillation frequency with frequency meter.The assignable root cause was determined to be traced to component failure from wear.
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Search Alerts/Recalls
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