DEPUY SYNTHES PRODUCTS LLC KINCISE¿ FEM HEAD IMPACTOR, REPLACE CAP; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1013-00-901 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a total hip replacement surgical procedure it was observed that the femoral head of the impactor device broke in half.It was reported that all pieces were collected.There was no reported delay in the procedure due to the event.It was not reported if a spare device was available for use.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: 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.Udi - (b)(4).
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Search Alerts/Recalls
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