MONOTEX

Description of Event or Problem

ACCORDING TO THE REPORTER, "CUSTOMER STATED THAT SOON AS THEY PULL THE SUTURE OUT OF THE SEALED PACKAGE THE NEEDLE DETACHES FROM THE THREAD."

Additional Manufacturer Narrative

4 DOZEN RETURN SAMPLES WERE OBTAINED AND NEEDLE ATTACHMENT TESTING WAS PERFORMED PER THE USP STANDARD. NEEDLE ATTACHMENT STRENGTH MET ALL REQUIREMENTS.TENSILE TESTING WAS ALSO PERFORMED ON THE RETURNED SAMPLES. AVERAGE TENSILE STRENGTH OF THE SAMPLES MEASURED 86.6% ABOVE THE USP REQUIREMENT (0.44LBF) AND THE RIVERPOINT REQUIREMENT (0.44LBF) FOR SIZE 6-0 PTFE. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE REPORT COULD NOT SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY FDA.