GENDER SOLUTIONS PFJ TROCHLEA COMPONENT

Additional Manufacturer Narrative

THE PRODUCT WAS IMPLANTED; THEREFORE, IT WAS NOT AVAILABLE FOR RETURN OR EVALUATION. THE DEVICE WAS USED FOR TREATMENT. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND AS PART OF CORRECTIVE ACTION, A NEW SUPPLIER FOR THE POLYETHYLENE BAGS HAS BEEN SELECTED AND TESTING COMPLETED TO ENSURE THERMAL RELIABILITY AND STABILITY OF THE NEW BAGS. FIELD ACTION Z-0845-2016 WAS INITIATED ON JANUARY 11, 2016 TO REMOVE REMAINING AFFECTED UNITS FROM THE FIELD. THIS FIELD ACTION CONTAINS THE RELATED PART AND LOT NUMBER. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.

Description of Event or Problem

IT WAS REPORTED THAT THE INNER PLASTIC BAG PACKAGING WAS STUCK TO THE IMPLANT.