HU-FRIEDY #9 DEAN SCISSORS

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO HU-FRIEDY MFG. CO., LLC AFTER THE INITIAL REPORT WAS FILED. ANALYSIS OF THE RETURNED INSTRUMENT REVEALED THAT IT WAS PAST ITS LIFE EXPECTANCY. LOT NUMBER HAS BEEN UPDATED. DEVICE WAS RETURNED TO MANUFACTURER. THIS IS A FOLLOW-UP REPORT THIS FOLLOW-UP REPORT PROVIDES ADDITIONAL INFORMATION AND DEVICE EVALUATION. DEVICE WAS RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE HAS BEEN PROVIDED. H6 - METHOD, RESULT AND CONCLUSION CODES HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THERE IS NO RELEVANT HISTORY. HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. IN THIS INSTANCE, THE LOT NUMBER IS WAS NOT PROVIDED BY THE INITIAL REPORTER. THE DEVICE INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. PMA/510(K) IS NOT APPLICABLE. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED TO HU-FRIEDY CO., LLC THAT DURING AN ORAL SURGERY PROCEDURE, THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE BROKEN TIP WAS SWALLOWED. THE BROKEN TIP WAS LATER RETRIEVED FROM THE SMALL INTESTINE USING AN ENDOSCOPE.