Additional data: b5, d9, g3, g6, h2, h3, h6, h10.During visual inspection, score marks were observed on the rod, consistent with expected markings due to incremental distraction.Inspection of the returned rod revealed the distraction rod was functionally able to be lengthened by hand, which would indicate a broken locking pin.The reported failure mode is therefore confirmed, as distraction rod loose was able to be lengthened by hand.Because the locking pin is broken, there is nothing constraining the axial motion of the distraction rod within the housing tube.The pistoning action of the distraction rod due to a broken locking pin would allow for fluid ingress into the actuator.Liquid extrusion was also confirmed as the rod pistoned.In addition, sectioning the rod confirmed the broken locking pin.The patient's unique anatomy and/or daily activities are possible causes of the reported failure.The iqc inspection data for the lot of locking pin was reviewed, and the parts met design specifications per the engineering drawings.As part of the investigation, the work order was reviewed, and confirmed the device passed all inspections per the acceptance tests prior to shipment.
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