Method: risk assessment.Result: the customer reported event was confirmed via x ray review.The x rays show both screws fractured at the screw shank.As the device is still implanted, inspection and material analysis could not be performed.The lot number is unknown, so a manufacturing record review could not be completed.The screws were implanted for about 6 months.According to the xia ifu, "the surgeon must discuss all physical and psychological limitations inherent to the use of these devices with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion should be directed to the issues of premature weight bearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.Conclusion: as the device was not returned, a definite root cause cannot be determined.Possible root causes as defined in the risk table include excessive patient post op activity, patient non fusion, poor bone quality, surgeon applying too much torque to the blockers, poor fixation construct, improper screw hole prep, and improper screw insertion.
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