DEPUY SYNTHES PRODUCTS LLC KINCISE BROACH-ADAPTER-ANTERIOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1010-01-102 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device date of manufacture is unknown; therefore, udi: (b)(4).Device manufacture date is 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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This is report 2 of 4 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the (4) adaptor devices were flipping open during impaction.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.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 device manufacture date was documented as unknown in the initial report.It has been updated to august 29, 2017.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.During review of the device manufacturing records for this device it was found that there were no anomalies that occurred during the manufacturing or processing of the device that would have been expected to cause or contribute to the reported event.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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