SYMBOTE COMPOSITE MESH/15 CM X 10 CM

Additional Manufacturer Narrative

(B)(4). (B)(6). (B)(4).

Description of Event or Problem

ACCORDING TO THE REPORTER, ON (B)(6) 2016, THE SURGEON USED A MESH FOR A VENTRAL HERNIA REPAIR. THE MESH WAS FIXED WITH SUTURES, LAST WEEK ON (B)(6) 2016 THE PATIENT RETURNED BECAUSE OF ACUTE UNREPORTABLE HERNIA IN THE SAME LOCATION. THE SURGEON PERFORMED A SURGERY AND FOUND THAT THERE WERE HOLES IN THE CENTER OF THE MESH. THE SURGEON TOOK OUT THE MESH FOR INSPECTION AND REPLACED IT WITH ANOTHER MESH. THERE WASN`T ANY ISSUES WITH THE MESH AT TIME OF IMPLANT. THE LAST KNOWN PATIENT STATUS IS REPORT AS GOOD AND HAS LEFT THE HOSPITAL.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR?, EVALUATION CODES, DATE RECEIVED BY MFR, TYPE OF REPORTS. POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SYM1510 MESH. THE MESH WAS RETURNED PARTIALLY INTEGRATED WITH HUMAN TISSUE. VISUAL INSPECTION NOTED A 5 CM HOLE PRESENT IN THE CENTER OF THE MESH, AND A SECOND, SMALLER HOLE PRESENT ON THE OPPOSITE OF THE GREEN MARKING. THE WHITE TEXTILE OF THE MESH WAS NOTED TO BE FRAYING AND OVERSTRETCHED AND SUTURE POINTS WERE NOTED CLOSE TO THE GREEN MARKING. DUE TO THE NATURE OF THE RETURNED MESH, NO FUNCTIONAL EVALUATION COULD BE COMPLETED. BASED ON THE SIZE AND SHAPE OF THE HOLES IN THE MESH, AND THE LOCATION OF THE SUTURE POINTS, THE MOST LIKELY ROOT CAUSE OF THE TORN MESH IS OVERSTRETCHING DUE TO EXCESSIVE TENSION. THE PRODUCT IFU WHICH ACCOMPANIES EACH DEVICE STATES THAT ¿IN ORDER TO MAINTAIN THE ELASTICITY AND THE POROSITY OF THE REINFORCEMENT, IT IS RECOMMENDED THAT THE MESH SHOULD NOT BE OVERLY STRETCHED WHEN IT IS BEING PUT IN PLACE. A MODERATE AND EQUAL TENSION SHOULD BE APPLIED IN ALL DIRECTIONS FOR FIXATION IN ORDER TO ACCOUNT FOR WOUND SHRINKAGE DURING THE HEALING PROCESS.¿ A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THIS LOT OF PRODUCTS WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. NO TRENDS FOR THIS FAILURE MODE HAVE BEEN DETECTED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

Additional Manufacturer Narrative

MANUFACTURER'S REFERENCE NUMBER: (B)(4).