Visual inspection of the returned nail revealed, that the housing tube had cracks at the anti-rotation lug and the crown region.Based on visual inspection, the reported failure was confirmed.The x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The iqc inspection data for the lots of anti-rotation lug and housing tube was reviewed and confirmed the parts met design specifications, per the engineering drawings.The work order was reviewed and confirmed, the device passed all inspections per the acceptance tests.The anti-rotation lug being cracked, indicates the type of breakage that can be a result of excess stress (torsional force) that is applied to the nail as a result of the patient¿s daily activities.
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