DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1000-00-101 |
Device Problems
Unintended System Motion (1430); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
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.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the device was firing incorrectly was confirmed.The device was visually inspected, and it was found that the device passed visual inspection.The device was visually and functionally assessed and determined not to impact, and the anvil automatically extends when manually retracted due to trap internal pressure.This is considered premature wear of the seals.It was further determined that the device failed pre- tests for impactor operation assessment.The assignable root cause of these conditions was determined to be traced to component failure due to wear.(b)(4).
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Event Description
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It was reported that during testing it was observed that the impactor device was firing incorrectly.During in-house engineering evaluation it was determined that device did not impact, and the anvil automatically extends when manually retracted due to trap internal pressure.This event did not occur during surgery.There was no patient involvement.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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Search Alerts/Recalls
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