Model Number 48994150 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Fracture (1260)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2017 |
Event Type
malfunction
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Event Description
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It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.
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Manufacturer Narrative
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The fracture of a drill tip was confirmed via visual inspection.Per analysis, the tip fractured due to unidirectional bending.No material and manufacturing defects were found.The plausible root cause is applying too much cantilever force to the drill.
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Event Description
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It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.
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Search Alerts/Recalls
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