TPRLC 133 FP TYPE1 PPS HO 6.0 T1

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS RETURNED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED THAT THERE IS FOREIGN MATERIAL IN STERILE PACKAGE; FOAM AND POROUS DEBRIS IN STERILE PACKAGING. THE TYVEK LID HAS BEEN DELAMINATED WHEN OPENING THE STERILE PACKAGE TO INSPECT INNER PACKAGING CONTENTS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE FOREIGN DEBRIS IS THE OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDED. A CORRECTIVE ACTION WAS RAISED TO FURTHER INVESTIGATE THE FOREIGN DEBRIS WITHIN THE STERILE BARRIER. THE ROOT CAUSE OF THE TYVEK DELAMINATION IS AN ISSUE WITH THE TYVEK LIDS PROVIDED TO ZB BY THE APPROVED SUPPLIER. THE MANUFACTURER OF THE TYVEK LID WAS AWARE OF THE ISSUE DETAILED IN THE REPORTED EVENTS, AND HAVE DETERMINED IT TO BE DUE TO A PROCESS CHANGE. A CORRECTIVE ACTION WAS RAISED TO FURTHER INVESTIGATE SIMILAR TYVEK DELAMINATION ISSUES. THE ROOT CAUSE OF THE FOAM DEBRIS IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED, AND THE ROOT CAUSE OF THE POROUS COATING DEBRIS IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE POROUS COATING TO SHED FROM THE IMPLANT. THIS DEVICE FALLS WITHIN THE SCOPE OF A CURRENT CAPA, THE PURPOSE OF WHICH IS TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS CAPA, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B(4). FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED BY THE INCOMING INSPECTION TEAM, FOUND DEBRIS IN THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.