No description of the foreign material was provided, or is available.Pictures of the foreign material were requested, but were also unavailable.Zimmer biomet (b)(4) stated that upon receipt at their facility, the foreign material did not appear to be present.The screw was received for evaluation along with its packaging, and the screw was autoclaved upon receipt.Visual inspection of the returned screw after autoclaving noted white material on the inner diameter of the screw between 2 or 3 screw threads which is barely visible without magnification.The composition of the residue was noted as consistent with sanitizing solution.It has also been noted that a red/brown stain appears on the inner surface of the tyvek lid.Packaging cosmetic criteria was reviewed, finding the lid as received would be acceptable in the manufacturing environment, although it cannot be determined when the stain occurred.Review of the device history record did not find any deviations or anomalies.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combination.Since there is no information on the foreign material on the screw, a definite root cause cannot be determined with the information provided.
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