DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1000-00-101 |
Device Problems
Fracture (1260); Unintended System Motion (1430)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an unspecified surgical procedure, it was discovered that the impactor device housing that connected the handle to the rest of the device broke during use.During in-house engineering evaluation, it was observed that the device operated unintendedly as the rear housings were separated from the mid-plate apart and the loose trigger.The rear housing separation from the mid-plate was due to the trigger screw coming loose.It was determined that the kincise surgical impactor trigger screw had back out, which allowed the trigger body to move, resulting in the rear housing separation.It was further determined that the device failed pretest for visual assessment.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.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 report 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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition that the device had unintended activation/motion, identified during service and repair, was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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