DEPUY SYNTHES PRODUCTS LLC KINCISE BROACH-ADAPTER-ANTERIOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1010-01-102 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant device: adapter device.The device manufacture date was not available.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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This is event 1 of 2 of the same event.It was reported that during an unspecified surgical procedure, it was observed that two adapter devices were not locking properly and kept popping open.It was unknown if there were delays 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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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.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not 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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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.Additional information: the date of manufacture was reported as unknown in the initial report.It has been updated as 8/29/2017.Therefore, udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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