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Catalog Number 05.001.201 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.H10 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 (b)(6) that during an unspecified surgical procedure, it was observed that the lid device was releasing from the battery handpiece device when used in the saw mode and cutting the bone by the pressure exerted on the bone.It was reported that there was an unspecified surgical delay.It was not reported whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2021.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 event included a concomitant lid device and therefore this event is 1 of 2.D11, concomitant medical devices and therapy dates, lid device, (b)(6) 2021.
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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.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the reported condition of the lid device releasing from the handpiece was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device had illegible etch, component damage, corrosion/rusting/pitting and failed pre-test for check the incompatibility of the lid of the saw, check function of all possible modes with the power module lid, marking and labeling and general condition due to component wear.
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Search Alerts/Recalls
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