BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK (SEE H11)

    MDR report key: 18984875 · Received March 27, 2024

    Report

    Report Number
    3003639970-2024-00114
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Report Date
    April 5, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K170661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: WE HAVE RECEIVED 5 CASES OF THE POSSIBLE CODE-BATCHES C3046041-122057, C3046630-122456 AND C3046630- 123182, REGARDING THE SAME ISSUE FROM THE SAME CUSTOMER AT THE SAME TIME. THERE ARE NO PREVIOUS COMPLAINTS OF THESE CODE-BATCHES OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE CODE-BATCH C3046041-122057, (B)(4) UNITS OF THE CODE-BATCH C3046630-122456 AND (B)(4) UNITS OF THE CODE-BATCH C3046630-123182. THERE ARE NO UNITS IN OUR STOCK OF THESE CODE-BATCHES. WE HAVE RECEIVED (B)(4) UNOPENED UNITS OF C3046041-122057; (B)(4) UNOPENED UNITS AND 1 OPEN UNIT (ONLY WITHOUT SECONDARY PACKAGE) OF C3046630-122456; (B)(4) UNOPENED UNITS OF C3046630-123182 TO ANALYZE THE FIVE CASES RECEIVED. WE HAVE ALSO RECEIVED TWO PICTURES SHOWING THE KELOIDS DEVELOPED IN ONE OF THE PATIENTS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.35 KGF IN AVERAGE AND 1.23 KGF IN MINIMUM FOR CODE-BATCH C3046041-122057, 1.45 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM FOR CODE-BATCH C3046630-123182, 1.55 KGF IN AVERAGE AND 1.43 KGF IN MINIMUM FOR CODE-BATCH C3046630-122456. EP REQUIREMENTS: 1.27 KGF IN AVERAGE AND 0.76 KGF IN MINIMUM. DEGRADATION TEST RESULTS CONDUCTED ON THE CLOSED SAMPLES RECEIVED AFTER 7 DAYS IN A 0,9% NACL SOLUTION AT 37ºC ARE 0.56 KGF IN MAXIMUM AND 0.30 KGF IN MINIMUM FOR CODE-BATCH C3046041-122057; 0.50 KGF IN MAXIMUM AND 0.37 KGF IN MINIMUM FOR CODE-BATCH C3046630-123182 AND 0.42 KGF IN MAXIMUM AND 0.28 KGF IN MINIMUM FOR CODE-BATCH C3046630-122456 AND FULFIL BRAUN SURGICAL REQUIREMENTS: 0.96 KGF IN MAXIMUM AND 0.23 KGF IN MINIMUM. THESE VALUES ARE THE USUAL AND THE CURRENT ONES FOR THESE THREADS AND SIZES. IT HAS NOT BEEN POSSIBLE TO CORRELATE THE DEVELOPMENT OF KELOIDS WITH NOVOSYN QUICK. IN OUR SKINNOQ STUDY A SUBCUTANEOUS HAEMATOMA WAS OBSERVED IN ADULTS AND THIS IS WHY THE SUTURE WAS REMOVED(1). NO COMPLICATIONS RELATED TO WOUND HEALING WERE OBSERVED DURING THE 3-MONTH STUDY DURATION(1). THE OCCURRENCE OF KELOIDS COULD BE DUE TO THE TYPE OF SUTURE USED FOR WOUND CLOSURE(2) BUT ALSO TO PATIENT-RELATED FACTORS(2-7) AND THE SUTURING TECHNIQUE (2). FOR EXAMPLE, DIABETES (2), OBESITY (2), SKIN COLOUR (2),(5-8) (KELOIDS ARE 15 TIMES MORE COMMON IN PATIENTS WITH DARKER SKIN THAN IN PATIENTS WITH LIGHTER SKIN (4),(8)) AND FAMILY HISTORY OF POOR WOUND HEALING (4),(6) HAVE A POSITIVE INFLUENCE ON THE APPEARANCE OF KELOIDS. ON THE OTHER HAND, TO REDUCE TENSION IN THE DERMIS (AND THUS PREVENT THE APPEARANCE OF KELOIDS) IT IS IMPORTANT TO ACCESS THE SUPERFICIAL AND DEEP FASCIA (4). IN THIS WAY THE EDGES OF THE WOUND ARE APPROXIMATED IN THE MOST NATURAL WAY POSSIBLE (4). THEREFORE, WITH THE INFORMATION WE HAVE, WE CANNOT DIRECTLY RELATE THE APPEARANCE OF KELOIDS IN THE FIVE PATIENTS TO THE USE OF NOVOSYN QUICK. WE CANNOT RULE OUT THAT THESE PATIENTS HAVE A PREDISPOSITION TO FORM KELOIDS OR THAT THE SUTURING TECHNIQUE USED IN THESE PATIENTS DID NOT INFLUENCE THE FORMATION OF PATHOLOGICAL SCARS. REFERENCES: (1). GFROERER, S., BAUMANN, P., SCHWALBACH, A. K., & SMIRNOFF, A. (2019). PROSPECTIVE INTERNATIONAL MULTICENTER OBSERVATIONAL STUDY OF NOVOSYN® QUICK FOR SKIN CLOSURES IN ADULTS AND CHILDREN (SKINNOQ). BMC SURGERY, 19(1), 47. HTTPS://DOI.ORG/10.1186/S12893-019-0506-8. (2). GRABOWSKI, G., PACANA, M. J., & CHEN, E. (2020). KELOID AND HYPERTROPHIC SCAR FORMATION, PREVENTION, AND MANAGEMENT: STANDARD REVIEW OF ABNORMAL SCARRING IN ORTHOPAEDIC SURGERY. THE JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS, 28(10), E408-E414. HTTPS://DOI.ORG/10.5435/JAAOS-D-19-00690. (3). JUCKETT, G., & HARTMAN-ADAMS, H. (2009). MANAGEMENT OF KELOIDS AND HYPERTROPHIC SCARS. AMERICAN FAMILY PHYSICIAN, 80(3), 253-260. (4). OGAWA, R. (2017). KELOID AND HYPERTROPHIC SCARS ARE THE RESULT OF CHRONIC INFLAMMATION IN THE RETICULAR DERMIS. INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 18(3), 606. HTTPS://DOI.ORG/10.3390/IJMS18030606. (5). LUDMANN, P. (2022). KELOID SCARS: OVERVIEW. AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION, HTTPS://WWW.AAD.ORG/PUBLIC/DISEASES/A-Z/KELOIDS-OVERVIEW. (6). LUDMANN, P. (2022). KELOID SCARS: CAUSES. AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION, HTTPS://WWW.AAD.ORG/PUBLIC/DISEASES/A-Z/KELOIDS-CAUSES. (7). OLIVEIRA, G. V., METSAVAHT, L. D., KADUNC, B. V., JEDWAB, S. K. K., BRESSAN, M. S., STOLF, H. O., CASTRO, R. G., BEZERRA, S. M. F. M. C., CALIL, D. A., ADDOR, F. A. Z., FRAGA, J. C. S., REIS, C. M. S., REIS-FILHO, E., SILVA, M. R., RAMOS-E-SILVA, M., & HEXSEL, D. M. (2021). TREATMENT OF KELOIDS AND HYPERTROPHIC SCARS. POSITION STATEMENT OF THE BRAZILIAN EXPERT GROUP GREMCIQ. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 35(11), 2128-2142. HTTPS://DOI.ORG/10.1111/JDV.17484. (8). CHIKE-OBI, C. J., COLE, P. D., & BRISSETT, A. E. (2009). KELOIDS: PATHOGENESIS, CLINICAL FEATURES, AND MANAGEMENT. SEMINARS IN PLASTIC SURGERY, 23(3), 178-184. HTTPS://DOI.ORG/10.1055/S-0029-1224797. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLES RECEIVED COMPLY WITH USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. CORRECTIVE MEASURES: ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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.

    Additional Manufacturer Narrative · 0

    INVOLVED CODE-NUMBER IS UNKNOWN. POSSIBLE PRODUCTS INVOLVED: D1; BRAND NAME: NOVOSYN QUICK UNDY 3/0(2)70CM HR26(M)DDP OR NOVOSYN QUICK UNDY 3/0(2)45CM DSMP19MDDP. D4; MODEL AND CATALOG NUMBER: C3046041 OR C3046630 RESPECTIVELY. LOT NUMBER: 122057 (FOR THE MODEL NUMBER C3046041) OR 123182 OR 122456 (FOR THE MODEL NUMBER C3046630). IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT KELOIDS WERE DETECTED IN THE LATE FOLLOW-UP (ONE YEAR) OF THE SCARS HAVE APPEARED IN 5 PATIENTS WHO UNDERWENT RHINOPLASTY AND OTOPLASTY (PLASTIC SURGERY SERVICE). THE SURGEON ARGUES THAT THE CAUSE IS THE NOVOSYN QUICK SUTURE, SINCE THE KELOIDS COINCIDE WITH THE PASSAGE POINTS OF THE SUTURE THREAD. THE INCIDENT IS PROCESSED FROM THE PHARMACY. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441081 NOVOSYN QUICK (SEE H11) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. SEE H11 SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose