Catalog Number UNK_SPN |
Device Problems
Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2017 |
Event Type
malfunction
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Event Description
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It was reported that a t1-t6 thoracic fracture fixation was being done and during final tightening one of the screws and both the blade and blocker snapped off within the final tightening tube.It was further reported that two blockers were placed down the final tightening tube causing excessive stress on the screw design.There was a surgical delay of 40 minutes.Case was finished without further issue and the fixation was completed as planned pre-op.Update: the blockers were tightened to a torque of 12nm - no more than the recommended amount.The blocker was not cross-threaded.No part/s of the blocker broke, the blades were broken and both they and the blocker/s were lodged within the final tightening tube.The screw blades, the screw tulip head remained intact.Two blockers were placed down the ft tube (surgeon was not aware of an existing blocker).All fragments remained within the final tightening tube.X-ray did not show any additional fragments the surgeon was concerned with.No other adverse consequences for the patient.Parts were disposed.
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Manufacturer Narrative
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Method: risk assessment; results: the devices were discarded therefore device evaluation, device history review and complaint history review could not be performed.Conclusion: the possible root cause of the reported event is user error.
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Event Description
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It was reported that a t1-t6 thoracic fracture fixation was being done and during final tightening, one of the screws and both the blade and blocker snapped off within the final tightening tube.It was further reported that two blockers were placed down the final tightening tube causing excessive stress on the screw design.There was a surgical delay of 40 minutes.Case was finished without further issue and the fixation was completed as planned pre-op.Update: the blockers were tightened to a torque of 12nm - no more than the recommended amount.The blocker was not cross-threaded.No part/s of the blocker broke, the blades were broken and both they and the blocker/s were lodged within the final tightening tube.The screw blades, the screw tulip head remained intact.Two blockers were placed down the ft tube (surgeon was not aware of an existing blocker).All fragments remained within the final tightening tube.X-ray did not show any additional fragments the surgeon was concerned with.No other adverse consequences for the patient.Parts were disposed.
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Search Alerts/Recalls
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