Catalog Number 2107-1015 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981); Mechanics Altered (2984)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The surgeon reported via the rep that a screwdriver from a trident set became twisted and could not engage with the screw correctly.There were no adverse events or delays related to this reported issue and that the surgery was completed as planned using an item from another kit.
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Manufacturer Narrative
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An event regarding damage (deformation) involving a trident driver shaft was reported.The event was confirmed.Visual inspection shows the hexalobular driver tip is deformed.The deformation of the tip indicates that it was damaged while the device being used to tighten a screw.Examination of the returned device with material analysis engineer indicated the damage observed is consistent with in-service use.Medical records received and evaluation: not performed as patient factors did not contribute to event.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 1 other events for the lot referenced regarding damage to the hexalobular driver tip.Visual inspection confirms the reported event which shows that the hexalobular driver tip is deformed.The deformation of the tip indicates that it was damaged while the device being used to tighten a screw.The returned device was consulted with material analysis engineer, concluded that the damage observed is consistent with in-service use.
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Event Description
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The surgeon reported via the rep that a screwdriver from a trident set became twisted and could not engage with the screw correctly.There were no adverse events or delays related to this reported issue and that the surgery was completed as planned using an item from another kit.
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Search Alerts/Recalls
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