Model Number 6134.0185 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Spinal Column Injury (2081)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not available as it remains in the patient.It was reported that the creo mis locking cap driver tip sheared off.It cannot be confirmed what step during the procedure the fracture occurred during because surgical conditions cannot be replicated.Because of this, it cannot be determined if the fracture was caused by excessive forces or surgical misuse.No determinations could be made as to the cause of the reported issue.
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Event Description
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It was reported that during a case the tip of the locking cap driver broke off and was retained in the patient post operatively.
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Manufacturer Narrative
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The device was returned for evaluation.It was reported that the creo mis locking cap driver tip sheared and was left in the patient.The deformation to the driver tip past the fracture point is consistent with clockwise torsional forces, meaning the tip was deformed during tightening.This is evidence of excessive force on the driver tip.Because it was not confirmed at what stage of the procedure the locking cap driver was being used for, no determinations could be made as to the cause of the reported issue.
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Event Description
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It was reported that during a case the tip of the locking cap driver broke off and was retained in the patient post operatively.
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Search Alerts/Recalls
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