POLYSORB

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING AN OPEN PROSTATECTOMY, THE NEEDLE BROKE AND PART OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE PART OF THE NEEDLE THAT FELL INTO CAVITY WAS NOT FOUND AND REMAINED IN PATIENT'S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. NO FURTHER TREATMENT WAS PLANNED.

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.