DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Model Number 1000-00-101 |
Device Problems
Material Fragmentation (1261); 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 06/15/2023 |
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 the impactor device was broken in the center, at the connection point between the base and the barrel, causing the device to separate and continuously impact without pressing the trigger.It was reported that there were no delays to the surgical procedure.It was not reported 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.E1: the initial reporter's facility address and phone number were not provided.As of this date, the device has not been returned for evaluation.Therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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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, it was determined that the reported condition that the device was broken causing the device to separate and continuously impact without pressing the trigger was not confirmed.Therefore, an assignable root cause for the reported condition of unintended activation/motion and device fractured was not determined.However, during evaluation, it was determined that the device would not run and was loose.It was further determined that the device failed pretest for visual assessment, impactor operation assessment and final assessment.The assignable root cause was determined to be due to component failure from wear.
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Search Alerts/Recalls
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