DIAM.B.S.PREP.CONIC. FG M 010

Additional Manufacturer Narrative

INVESTIGATION: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED BUR IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1876802). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE (MOTOR SETTING NOT COMMUNICATED), OVERUSE (NUMBER OF USES NOT COMMUNICATED), EXCESSIVE WEAR, OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). ROOT CAUSES ARE NOT IDENTIFIED.

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 A DIAM.B.S.PREP.CONIC. FG M 010 BUR BROKE DURING USE. THE USER DOES NOT KNOW WHAT HAPPENED TO THE BROKEN PART. IT IS ASSUMED THAT THEY WERE SWALLOWED BY THE PATIENT. FURTHER INFORMATION REQUESTED.