Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence with the sales rep.The device was returned - and the reported screw fracture was confirmed through visual inspection.All broken fragments were retrieved.The event lead to 30 minutes surgical delay.Manufacturing history review revealed no relevant anomalies.Result: based on the visual inspection on the returned units, the plausible root cause of the reported event are excessive torque applied during implant expansion in-situ, user applies off-axis loading during expansion, inserter not assembles correctly to implant.
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