Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at the guidewire¿s distal tip.The second half of the tip was not returned for analysis as it remained in the vertebral body of patient.Device was then sent for fracture analysis.The fracture analysis suggests that the tip underwent a static overload failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the guidewire tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the tip underwent a static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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