GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE PROXIMAL CIRCUMFLEX. A 2.8X16MM GRAFTMASTER WAS DEPLOYED TO TREAT A PERFORATION; HOWEVER ONLY 50% OF THE LESION WAS NOTED TO BE COVERED, THEREFORE AN ADDITIONAL GRAFTMASTER WAS DEPLOYED TO FULLY COVER THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICAL DELAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.