RADIX ANCHOR DRILLS ROOT FACER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BROKEN PIECE WAS RETRIEVED, AND NO INJURY RESULTED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1661113). THE THREE RETURNED ROOT FACERS RADIX 1 HAVE NO VISUAL DAMAGE, SEEM UNUSED. THE INVOLVED DRILLS WHICH HAVE BROKEN DURING TREATMENT HAVE NOT BEEN RETURNED AND CANNOT BE ANALYZED. NOTABLY, THE PLACE WHERE THE BREAKAGES OCCURRED REMAINS UNCERTAIN. NO TEST IS APPLICABLE ON THE ROOT FACERS RADIX 1. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, THE PIVOT PART DIAMETERS HAVE BEEN MEASURED AND ARE MATCHING TO THE DRAWING. GENERALLY SPEAKING, THE ROOT FACERS MUST BE USED ONLY IN A STRAIGHT LINE, WITHOUT GIVING BENDING MOVEMENT.

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. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1661113). THE THREE RETURNED ROOT FACERS RADIX 1 HAVE NO VISUAL DAMAGE, SEEM UNUSED. THE INVOLVED DRILLS WHICH HAVE BROKEN DURING TREATMENT HAVE NOT BEEN RETURNED AND CANNOT BE ANALYZED. NOTABLY, THE PLACE WHERE THE BREAKAGES OCCURRED REMAINS UNCERTAIN. NO TEST IS APPLICABLE ON THE ROOT FACERS RADIX 1. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, THE PIVOT PART DIAMETERS HAVE BEEN MEASURED AND ARE MATCHING TO THE DRAWING. GENERALLY SPEAKING, THE ROOT FACERS MUST BE USED ONLY IN A STRAIGHT LINE, WITHOUT GIVING BENDING MOVEMENT.

Description of Event or Problem

IN THIS EVENT IT WAS REPORTED THAT A RADIX ROOT FACER SEPARATED DURING USE. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.