GRAFTON DBM

Additional Manufacturer Narrative

H9 CORRECTION NUMBER: Z-1323-2023; Z-1324-2023; Z-1325-2023; Z-1326-2023; Z-1327-2023; Z-1328-2023; Z-1329-2023; Z-1330-2023; Z-1331-2023; Z-1332-2023; Z-1333-2023; Z-1334-2023; THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GU IDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS; THIS IS NOT A NEW MALFUNCTION/EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GRAFTON. IT WAS REPORTED THAT THE PRODUCT BOX WAS OPENED AND THE INNER POUCH WAS NOT SEALED ON ONE SIDE. THE PRODUCT WAS NEVER COMPLETELY OPENED AS STERILITY WAS QUESTIONED AND NOT IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.