POLYSORB

Additional Manufacturer Narrative

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

ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE MATERIAL WAS TO BE USED FOR A BREAST OPERATION. HOWEVER, IT IMMEDIATELY BECAME APPARENT THAT THE NEEDLES WERE BROKEN UPON OPENING THE PACKAGE. THE NEEDLES THEREFORE WERE NOT USED. IT WAS NOTED THAT THE ENTIRE PACKAGE WAS AFFECTED. A NEW PACK WAS THEREFORE TAKEN AND THE OPERATION CONTINUED. THERE WAS NO PATIENT INJURY.