DEPUY SYNTHES PRODUCTS LLC KINCISE FEM HEAD IMPACTOR, REPLACE CAP; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1013-00-901 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
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 kincise device impactor head broke.All the pieces were retrieved.It was unknown if there was a delay in the surgical procedure or if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the date of manufacture was unknown 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.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.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the kincise replacement cap was broken in two pieces.The device also failed pretests for visual assessment, cloverleaf fitting assessments, adapter removal assessment, threaded fitting assessments, end cap thread assessment and keyless fitting assessment.This is consistent with having been dropped or misaligned during use which is user error.Therefore, the reported condition was confirmed.
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Search Alerts/Recalls
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