VNGD SSK 360 FEMUR L 57.5
Received Jun 1, 2018 · Event occurred May 2, 2018
Report 0001825034-2018-03738 · MDR key 7559951
Device
Product problems
- Packaging Problem
- Packaging Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). 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. 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. H3 OTHER TEXT : PRODUCT NOT RETURNED
Description of Event or Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND TO BE CRACKED AT STOCK INSPECTION.
Additional Manufacturer Narrative
(B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PACKAGING COMPONENTS CONFIRMED THE REPORTED EVENT AS THE STERILE BLISTER PACKAGING IS CRACKED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. IT WAS DETERMINED THAT THIN/VARIABLE BLISTER WALL THICKNESS AND NO HEAD-SPACE IN SHELF CARTON WERE CAUSING THE BLISTER TO DEFORM AND CRACK DURING DISTRIBUTION. THE PACKAGING DESIGN CONFIGURATION WAS CHANGED TO ADDRESS THIS ISSUE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.