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); Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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It was reported that the kincise device was firing but was broken along the seam.During in-house engineering evaluation, it was determined that the device operated unintendedly due to the rear housings separated from the mid-plate apart and the trigger was loose.The rear housing separating from the mid-plate due to the trigger screw coming loose, the trigger screw had backed out which allowed the trigger body to move resulting in the rear housing separation.The device also failed pretests for visual assessment, intermittent test assessment and final assessment.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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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.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to wear from degradation.(b)(4).
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Search Alerts/Recalls
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