Catalog Number I-K2869KF00 |
Device Problems
Difficult to Remove (1528); Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2014 |
Event Type
malfunction
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Event Description
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After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.
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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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Manufacturer Narrative
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An event regarding pin seizure involving a specialty triathlon guide was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis indicated the pin galled in the guide hole.No material or manufacturing defects were observed on the device features evaluated.-medical records received and evaluation: records were not provided.There is no indication the event is patient related.-device history review: the reported device was manufactured and accepted into final stock with no discrepancies.-complaint history review: there have been no other events for the reported lot id.Conclusions: the investigation concluded that the pin galled and seized in the guide hole.A capa was issued and a design change was implemented to add flutes to the bottom half of the pin.The fluted pins will allow the pin to act as a drill bit and clear any burrs or debris located on the inside surfaces of the cutting blocks/guides.The reported pin is contained within the scope of capa.
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Event Description
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After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.
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Search Alerts/Recalls
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