The cause of the tip breakage was most probably due to the k-wire not being removed after seating the screw which caused the k-wire to be impinged and caught in the screw making it difficult to remove.Reviewing the material certifications has determined that the material on the nitinol k-wire is astm 2063.This is an implantable grade of nitinol.Further review of the surgical technique describes to remove the k-wire once the screw is seated in the pedicle to prevent bending or impingement of the wire.This should be done prior to removing the screw driver.Review of manufacturing history record found a total of (b)(4) pieces of lot 1124151 were released for distribution on november 25, 2015 with no deviation or anomalies.A two-year complaint history review found this to be the first report received for this part number.As the root cause is likely related to surgical technique, and there is not a trend for reports of this nature, the need for corrective action was not indicated.
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