ARCOS LATERAL TROCH BOLT 30MM

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. FOREIGN: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT UPON OPENING THE PACKAGE FOR THE TROCHANTERIC BOLT, THE INNER PACKAGING HAD BROKEN DOWN AND DISINTEGRATED. THE BOLT WAS NOT USED AND NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE PROVIDED PHOTO FOUND THE INNER STERILE POUCH HAS BROKEN APART INTO PIECES. THE OUTER STERILE POUCH CANNOT BE FULLY EVALUATED IN THE PHOTOS PROVIDED AND THEREFORE, IT IS UNABLE TO CONFIRM IF STERILITY WAS BREACHED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE SUPPLIED STERILE INNER POUCH. 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.