FRONT LOADING CARTRIDGE KIT

Additional Manufacturer Narrative

(B)(4). REPORT SOURCE: (B)(6). MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001822565-2022-01253, 0001822565-2022-01254. 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 THAT THERE WAS DEBRIS IN THE STERILE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

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. VISUAL REVIEW OF THE RETURNED CASE CONFIRMED THAT TWO OF THE KITS RETURNED HAD LOOSE DEBRIS INSIDE THE OUTER SEALED CAVITY. THE DEBRIS WERE BOTH GREATER THAN .60 SQUARE MILLIMETERS, PER PACKAGING SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. AS THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET WAS NON-CONFORMING TO SPECIFICATION, THE ROOT CAUSE IS DETERMINED TO BE THE OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDED. 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.