Catalog Number 6541-4-518 |
Device Problems
Break (1069); Fracture (1260); Difficult to Remove (1528); Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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While drilling tibial baseplate trail, 1/8 drill with stop broke.No adverse consequences to the patient, surgery performed as normal.Also modular 4 in 1 capture getting stuck on cutting block.Not easy to remove.Information submitted was everything from both surgeon and hospital- no further details.
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture involving a triathlon drill bit was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause could be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.
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Event Description
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While drilling tibial baseplate trail, 1/8 drill with stop broke.No adverse consequences to the patient, surgery performed as normal.Also modular 4 in 1 capture getting stuck on cutting block.Not easy to remove.Information submitted was everything from both surgeon & hospital- no further details.
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Search Alerts/Recalls
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