DEPUY SYNTHES PRODUCTS LLC KINCISE AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1000-00-101 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an unspecified surgical procedure, it was observed that the trigger on the kincise impactor device did not function correctly during normal use.During in-house engineering evaluation, it was determined that the device latch was broken, pieces were missing which was consistent with being dropped, or engaged with excessive force and the trigger was observed to be difficult to press/depress.The device also failed pretests for visual assessment, latch assessment and intermittent test assessment and final assessment.There was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.There was no injuries, medical intervention or prolonged hospitalization reported.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 device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to improper maintenance and user error.
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Search Alerts/Recalls
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