The reported event that guide wire, ball-tipped, sterile t2 femur 3x1000 mm was alleged of packaging: residue outside sterile blister or pouch could not be confirmed, since the device was not received for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Furthermore, not enough information is available to confirm the reported case (like a photo).According to stock movement the device was already distributed in 2015 and no deviation was reported during incoming inspection at distribution site.It could not be excluded that the pollution occurred during storage at distribution site or at the user site itself, which is beyond the manufacturers control.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.Device was not returned.
|