PROTAPER GOLD ROTARY S2 21MM

Additional Manufacturer Narrative

CUSTOMER RETURNED 60X SEALED FILES. PER ANSI/AQ Z1.4-2003 INSPECTOR'S RULE (USING SINGLE SAMPLING PLAN 'NORMAL' AT INSPECTION LEVEL S2 WITH AQL 1.5), A SAMPLE LOT OF 8 WERE CHECKED. CHECKED 8 FILES UNDER MICROSCOPE AND FOUND NO MANUFACTURING MARKS OR DEFECTS. FILES WERE MEASURED USING OPT COMP-007 (CALIBRATION DATE 2/24/2025) AND PASSED ALL ATTRIBUTES CHECKED (WIRE SIZE, D2, D6, AND D13), SEE ATTACHED INSPECTION FORM. RETURN PRODUCT MET SPECIFICATION AND ENGINEERING REVIEWED AND ADVISED NO FURTHER TESTING NEEDED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. A QUERY INDICATES NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER.

Additional Manufacturer Narrative

AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT 2 PROTAPER GOLD ROTARY S2 21MM BROKE DURING USE IN THE SAME PATIENT. THE BROKEN PARTS COULD NOT BE RETRIEVED AND THEY WERE INCORPORATED INTO THE FILL. NO INJURY.