Visual examination of the returned device revealed the distal tip was fractured.The fractured tip was not returned.Fracture analysis was conducted which found plastic deformation and torsional shear markings following a circular pattern around the cannulation.This suggests that the fractured tip underwent a quasi-static torsional shear 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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the tap¿s distal tip breaking cannot be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static torsional shear 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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