No product evaluation can be completed as no product was returned.No images provided to confirm the malfunction.Due to lack of information the root cause cannot be determined and no additional investigation can be completed.Labeling review: ".Warnings, cautions, and precautions: use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
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