HI-LINE XS SIDE CUTTING, TC 1, 2.0 MM

Additional Manufacturer Narrative

CORRECTION - EVALUATION: DEVICE MANUFACTURE DATE 5/7/2020; QUANTITY 55. DEVICE HISTORY RECORDS (DHR) - THE DHR REVIEW DID NOT REVEAL ANY ABNORMALITIES IN THE MANUFACTURING PROCESS. NON-CONFORMANCE AND TRENDING REVIEW - THIS HAS BEEN DETERMINED TO BE AN ISOLATED INCIDENT BASED ON THE DEFECT RATE OF 0.01% (100 DPM). CONTAINMENT - THERE WAS 1 ADDITIONAL LOT MANUFACTURED AFTER THE AFFECTED LOT. THERE WERE ALSO NO MANUFACTURING ABNORMALITIES OBSERVED DURING MANUFACTURE. THERE WERE ZERO (0) INTERNAL NCMRS GENERATED, AND ZERO (0) CUSTOMER COMPLAINTS RECORDED. THERE IS NO OTHER PRODUCT POTENTIALLY AFFECTED. FAILURE INVESTIGATION - ROOT CAUSE IS UNKNOWN AND THERE WAS NO MANUFACTURING ERROR. ALL DIMENSIONAL MEASUREMENTS (IN-PROCESS AND FINAL INSPECTION) WERE WITHIN SPECIFICATION. A REVIEW OF THE MATERIAL CERTIFICATIONS SHOWED THAT THE MATERIAL WAS WITHIN SPECIFICATION. A LITERATURE SEARCH ON CARBIDE MATERIAL WAS ALSO PERFORMED. CARBIDE IS CLASSIFIED AS A BRITTLE MATERIAL AS IT EXHIBITS LITTLE TO NO PLASTIC DEFORMATION BEFORE THE INITIATION OF A TOTAL FAILURE. IMPROPER HANDLING OF THE DEVICE DURING USE MANY CAUSE FAILURE. CORRECTION AND/OR PREVENTIVE ACTION - NO SPECIFIC CORRECTIVE ACTIONS ARE DEEMED REQUIRED. DISPOSITION - PRODUCT WAS NOT RETURNED NOR RECEIVED.

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION OR INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A BURR. THE DEVICE BROKE WHILE BEING USED IN A CRANIO-MAXILLOFACIAL SURGERY. THE FRAGMENT, WHICH HAD FALLEN IN THE SURGICAL FIELD, WAS REMOVED WITHOUT ANY HARM TO THE PATIENT. THERE WAS A FIVE MINUTE DELAY DUE TO THE REPORTED EVENT. ANOOTHER BURR WAS OPENED IN ORDER TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.