Additional Manufacturer Narrative · 1
THE DISTRIBUTOR SENT US THE INSTRUMENT IN QUESTION FOR EVAL WITH A LETTER DATED 10-16-2007, INFORMING US THAT A MEDWATCH WAS RECEIVED FROM THE FDA STATING, "DOCTOR WAS USING THE STRULLY SCISSORS WHEN ONE OF THE BLADES SNAPPED OFF. DOCTOR IMMEDIATELY PICKED IT OUT OF THE BRAIN/SKULL AREA AND GAVE IT TO THE SCRUB NURSE WHO IN TURN GAVE IT TO ME. I PACKAGED IT, AND GAVE IT TO THE NEURO CLINICAL COORDINATOR". AS PER THE RESPECTIVE DISTRIBUTOR MEDWATCH REPOR, WHICH WAS SUBMITTED TO THE FDA IN 2007, THIS INCIDENT ALREADY HAPPENED ABOUT ONE MONTH BEFORE. AS PER THE DISTRIBUTOR, THE INSTRUMENT HAS NOT BEEN AVAILABLE EARLIER FOR EVAL AND BEFORE HAVING THE INSTRUMENT THE MFR COULD NOT BE CLEARLY DETERMINED. UNFORTUNATELY, NO INFO COULD BE GIVEN WHETHER ANY PT INJURY WAS IMPLICATED WITH THIS INCIDENT. THIS INCIDENT OCCURRED AT THE HOSPITAL. AT THE DISTRIBUTOR'S REQUEST, WE THOROUGHLY CHECKED THE AFFECTED INSTRUMENT IN OUR TESTING DEPT. FOLLOWING PERSON EVALUATED THE INSTRUMENT: GENERAL MGR AND DIRECTOR OF PRODUCTION. RESULTS: THE SCISSORS WERE MANUFACTURED IN A LOT OF 50 PCS IN MAY 2004 AND DELIVERED TO THE DISTRIBUTOR ON SEPTEMBER 16TH, 2004. BASED ON OUR TREND ANALYSIS RECORDS, WE CAN CONFIRM THAT SINCE 2003, WHEN WE STARTED DELIVERY OF THIS ITEM TO THE DISTRIBUTOR, WE HAVE DELIVERED A LARGE QUANTITY OF THIS ARTICLE WITHOUT RECEIVING ANY COMPLAINT OF THIS NATURE SO FAR. A THOROUGH REVIEW OF OUR PRODUCTION RECORDS CONFIRMS THAT THE RIGHT MATERIALS HAD BEEN USED AND THAT THE INSTRUMENTS HAD BEEN MANUFACTURED ACCORDING TO THE GIVEN STANDARDS AND PRODUCTIONS SPECIFICATIONS. THE HARDENING PROTOCOL CONFIRMS THE MEASURED HARDNESS TO BE 48,9 HRC (AVERAGE VALUE), WHAT IS WITHIN THE RANGE OF TOLERANCE OF HRC 48-56. WE ALSO PERFORMED A VISUAL INSPECTION OF THE FRACTURE UNDER MAGNIFICATION. CONCLUSION: BASED ON THE ANALYSIS OF THE FRACTURE WE ASSUME THAT A HAIRCRACK IN THE MATERIAL MIGHT HAVE CAUSED THE BREAK. AS TO WHEN THIS HAIRCRACK OCCURRED CANNOT BE RECONSTRUCTED. POSSIBLE CAUSES FOR HAIRCRACKS ARE MATERIAL DEFECTS AS WELL AS MISAPPLICATION OR MISUSE RESPECTIVELY IMPROPER MAINTENANCE. AS PER OUR TREND ANALYSIS RECORDS THIS IS THE FIRST TIME THAT WE HAVE BEEN MADE AWARE OF A COMPLAINT OF THIS NATURE, SO WE ARE OF THE OPINION THAT THIS IS AN ISOLATED AND NONRECURRING INCIDENT. BASED ON THIS WE FEEL THAT THERE IS NO NEED FOR ACTION AT THIS TIME AS PER THE CHANGE OF PRODUCTIONS PROCESSES OR USED MATERIALS.