During routine plate removal surgery, the driver tip broke when the surgeon was trying to remove distal 2.3mm screws.When the driver tip broke, the surgeon became frustrated and wound up breaking the bone while removing the plate with two screws still inserted in the plate.The break in the bone was filled with bone graft material.
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The driver that was used by the doctor is not the standard part used for this type plate.The driver used was cannulated while the driver that is normally used with this plate is a solid driver.The broken cannulated driver had a torsional fracture pattern at the break which likely indicates an excessive twisting load.This may occur when excessive force is applied to the driver to overcome increased resistance.A solid driver will be better able to withstand higher torque values than the cannulated driver.The two screws were still threaded in the locking holes of the plate when the parts were received.Using an in-house driver, the screws were able to be unthreaded as designed.The locking threads on the screws and the plate were intact and functioned properly.In general, the plate and screws showed wear consistent with being implanted and then being removed.This included bone growth on the threads and holes.Additionally, there was damage to the plate consistent with trying to pry it off the bone.The screws were damaged and bent and the head shows signs of wear, although both still functioned as designed.Additional mdrs associated with this event: mdr 3025141-2014-00159, driver.Mdr 3025141-2014-00161, screw 1.Mdr 3025141-2014-00162, screw 2.
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