GENDER SOLUTIONS PFJ TROCHLEA COMPONENT

Additional Manufacturer Narrative

(B)(4). INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE DEVICE IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE PART AND LOT COMBINATION OF THE DEVICE. 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 IS REPORTED THAT THE INNER PLASTIC PACKAGING WAS STUCK TO THE IMPLANT.