DEPUY SYNTHES PRODUCTS LLC KINCISE HEAD-ADAPTER-FEMORAL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1013-00-101 |
Device Problem
Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The date of manufacture was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported that during initial inspection, it was observed that the adapter device did not have a tip on it.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).The date of manufacture was document as unknown in the initial medwatch report.This information has been updated to may 4, 2017.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition was not confirmed.A photograph was provided by kincise which indicated that the cap was assembled on the device prior to shipping.Therefore, the assignable root cause could not be determined.A review of the device history record was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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