The surgeon reported that prior to implanting the ustar ii curved stem he noticed that the direction of bend was incorrect.He then implanted the ustar ii straight stem and completed the surgery without incident.No patient harm was reported.Examination of the device against the drawing confirmed that the stem is bent at a wrong angle, 180 degrees from that intended.Root cause investigation found that production does not have poka-yoke for the bending direction and that the testing process for identifying improper bending was inadequate.A recall of ustar ii curved stems is being conducted.Returned devices will be inspected, and the defective items destroyed.New devices will be produced and tested in accordance with the findings of the investigation.
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