MONOMAX VIOLET 1(4)200CM HRT48 LOOP(M

Additional Manufacturer Narrative

(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINTS: EGYPT. IT WAS REPORTED FROM THE GIT AND UROLOGY DEPARTMENT OF SEVERAL CASES OF ABDOMENS OPENING AFTER LAPAROTOMY INCISIONS WERE CLOSED.

Additional Manufacturer Narrative

SAMPLES RECEIVED: 1 UNOPENED POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. TIGHTNESS TEST TO THE SAMPLE RECEIVED HAS BEEN PERFORMED AND THE UNIT IS TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULT FULFILS THE OEM REQUIREMENTS. FURTHERMORE, DEGRADATION TEST (24 HOURS IN HCL 3M SOLUTION AT 37ºC) HAS BEEN CONDUCTED WITH THE SAMPLE RECEIVED AND THE RESULT FULFILS THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. AS INDICATED IN THE MODE OF ACTION IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: MONOMAX IS GRADUALLY DEGRADED BY HYDROLYSIS AND VIA ENZYMATIC PATHWAYS. THE DEGRADATION PROCESS LEADS TO A SUCCESSIVE DECREASE OF THE MATERIAL'S TENSILE STRENGTH AND FINALLY TO A COMPLETE MASS ABSORPTION OF THE FIBER. THE MASS ABSORPTION OF MONOMAX IS ESSENTIALLY COMPLETED IN BETWEEN 13 MONTHS AND MORE THAN 36 MONTHS, DEPENDING ON THE SIZE OF THE SUTURE MATERIAL AND THE PERFUSION OF THE TISSUE IN WHICH THE SUTURE IS IMPLANTED. IN THE WARNING NOTES/PRECAUTIONARY MEASURES FROM THE INSTRUCTIONS FOR USE OF THE PRODUCT IS IT ALSO EXPLAINED THAT: MONOMAX SHOULD BE USED APPLYING THE STANDARD SURGICAL SUTURING AND KNOTTING TECHNIQUES, TAKING INTO ACCOUNT THE SURGEON'S EXPERIENCE WITH THE RESPECTIVE SURGICAL PROCEDURE. CARE SHOULD BE TAKEN THAT THE KNOTS ARE POSITIONED PROPERLY AND ADEQUATE KNOT SECURITY IS GIVEN. AT LEAST A MINIMUM OF 4 CORRECTLY PLACED SQUARE AND FLAT KNOTS SHOULD BE DONE. WHEN WORKING WITH MONOMAX SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLE RECEIVED FULFILL THE OEM SPECIFICATIONS, NOTE OF THIS INCIDENT IS TAKEN IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.