CD HORIZON FENESTRATED SCREW SET

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FIX FOR TRAUMA FRACTURE. IT WAS REPORTED THAT A SCREW FRACTURED, AND A FRAGMENT WAS LEFT IN THE PATIENT. IT WAS NOTED THAT ONE OF THE SCREWS BROKE DURING THE REMOVAL OF IMPLANTS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DIFFICULTY NOTICED WHEN EXTRACTING SCREWS FOR ROUTINE REMOVAL OF METAL. TWO LOT NUMBERS WERE REPORTED AND IT IS UNSURE WHICH LOT WAS BROKE.

Additional Manufacturer Narrative

G2: COUNTRY OF ORIGIN - IRELAND. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.