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 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that during testing, it was observed that the housing from the impactor device was coming apart.During in-house engineering evaluation, it was observed that the device was operating.However, the trigger of the impactor was loose.The surgical impactor trigger screw had backed out, allowing the trigger body to move, and resulting in an unintended operation.It was further determined that the device failed pretest for visual assessment.The event was not related to surgery.There was no 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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device experiencing unintended activation/motion, identified during service and evaluation 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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