K-REAMER M-ACCESS 21MM 020

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. INVESTIGATION RESULTS: SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1745615). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE (HAND USED FILE - TECHNIQUE NO MORE VERIFIABLE TO DATE), OVERUSE (NUMBER OF USES NOT COMMUNICATED), EXCESSIVE WEAR, OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 21MM 020 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.