DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Model Number 1000-00-101 |
Device Problems
Unintended System Motion (1430); Device Slipped (1584); Detachment of Device or Device Component (2907)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 03/30/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an unspecified surgical procedure, it was discovered that the impactor device came part.It was not reported if there were any delays to the surgical procedure.It was not reported if a spare device was available for use.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.
|
|
Manufacturer Narrative
|
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: 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).
|
|
Manufacturer Narrative
|
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 had corrosion/rusting/pitting, foreign substance/debris/cleaning/sterilization, fracture, fluid ingress, component damage, missing component, and unintended activation/motion.It was further observed that the inner rib of device was broken away from housing on side.It was further determined that the device failed pretest for visual assessment, final assessment and intermittent test assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to the user, which is user error.
|
|
Search Alerts/Recalls
|
|
|