During the procedure when using the fibula nail 2, the entire surgical technique was followed for both the distal portion of the fibula, as well as the tip-loc as well.However, the tip-loc mechanism wouldn't allow the fibula 2 nail to go through the hole to connect together as one.Many different options were tried on attempting to get the devices to work as the technique called for however; it didn't work.The surgeon had to drop the tourniquet time, wait, and then use another company product with plates and screws instead of the fibula nail 2 device.Follow up was conducted and responses received indicated this was not a threading issue.The fibula nail 2 would not go through the eyelet of the tip-loc bushing properly, which lead to the inability to utilize the tip-loc technology mechanism.The delay in procedure was a 1 hour delay for the fibula nail 2 issue, but overall led to roughly a 3 hour delay including the plate and screw revision/salvage part of the case where the surgeon had to utilize another company's product since the tip-loc wouldn't work properly.This report is related to medwatch 3500a report number: 3025141-2022-00033 which was on the fibula nail 2 involved in this event.This report is for the tip-loc bushing & set screw kit.
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