The returned spacer was analyzed and the reported event of the broken spacer with a damaged spindle cap was confirmed.A visual inspection revealed damage and scratches on the body of the spacer, cam lobes, spindle cap and actuator shaft screw, as well as severe abrasion on the mating surface of the actuator.This damage to the spacer indicates the break was due to both the deployment against resistance, such as bone, and/or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Labeling states to not force deployment or spacer breakage or damage to bony structures may result.
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