BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 5/0 OR 6/0

    MDR report key: 12048115 · Received June 23, 2021

    Report

    Report Number
    3003639970-2021-00252
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Report Date
    September 15, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: LIST OF BATCHES DISTRIBUTED TO THE END CUSTOMER IN THE PERIOD 2020-2021 OF CODE C0023602: 120043, 120111, 120137, 120173, 120292, 120353, 120522 AND 121041. LIST OF BATCHES DISTRIBUTED TO THE END CUSTOMER IN THE PERIOD 2020-2021 OF CODE C2023613: 119305, 120031, 120081, 120245, 120323, 119085, 120533 AND 121051. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE CODE-BATCHES. WITHOUT ANY SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. NO SAMPLES RECEIVED FROM CUSTOMER AND NO UNITS IN OUR STOCK OF ANY OF THE POSSIBLE CODE-BATCHES. BATCH MANUFACTURING RECORD REVIEW OF THE POSSIBLE CODE-BATCHES. C0023602-120043: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.37 KGF IN AVERAGE AND 0.33 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120111: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.39 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120137: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.37 KGF IN AVERAGE AND 0.28 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120173: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.44 KGF IN AVERAGE AND 0.42 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120292: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.42 KGF IN AVERAGE AND 0.37 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120353: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.47 KGF IN AVERAGE AND 0.42 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-120522: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.50 KGF IN AVERAGE AND 0.48 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C0023602-121041: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.37 KGF IN AVERAGE AND 0.26 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.12 KGF FOR MINIMUM. C2023613-119305: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE IN THE PROCESS NEVERTHELESS, THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.76 KGF IN AVERAGE AND 0.63 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.15 KGF FOR MINIMUM. C2023613-120031: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. C2023613-120081: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. C2023613-120245: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. C2023613-120323: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE IN THE PROCESS NEVERTHELESS, THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. C2023613-119085: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE IN THE PROCESS NEVERTHELESS, THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MOREOVER, DEGRADATION TEST RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.81 KGF IN AVERAGE AND 0.74 KGF IN MINIMUM AND FULFIL B. BRAUN SURGICAL'S REQUIREMENT: 0.15 KGF FOR MINIMUM. C2023613-120533: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE IN THE PROCESS NEVERTHELESS, THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. C2023613-121051: WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. MODE OF ACTION OF MONOSYN (CONTAINED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT) WHEN MONOSYN® SUTURE MATERIALS ARE EMPLOYED, THERE IS A MILD INFLAMMATORY REACTION, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY. MONOSYN® IS METABOLISED TO GLYCOLIC ACID BY HYDROLYSIS WITHOUT CAUSING ANY ENDURING CHANGE IN THE REGION OF THE WOUND. APPROXIMATELY 50% OF THE ORIGINAL KNOT PULL TENSILE STRENGTH IS AVAILABLE AFTER 13 TO 14 DAYS. THE MASS DEGRADATION OF MONOSYN® IS ESSENTIALLY COMPLETED IN 60 TO 90 DAYS. SIDE EFFECTS OF MONOSYN (CONTAINED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT) AS FOR ALL SUTURES AFTER IMPLANTATION A TRANSIENT INFLAMMATION, TEMPORARY IRRITATION AND INFECTION AT THE WOUND SITE MAY OCCUR OCCASIONALLY. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. AN OCCASIONAL WOUND DEHISCENCE AND GRANULATION MAY NOT BE EXCLUDED. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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.

    Description of Event or Problem · 0

    FURTHER INFORMATION RECEIVED: TYPE OF SURGERY: GLUTENOPLASTY, CIRCULAR SUSPENSION, FEMOROPLASTY.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT FOR SEVERAL MONTHS, WITH DIFFERENT SURGEONS, PROBLEM WITH THE RESORPTION OF THE THREADS, 1 MONTH / 6 WEEKS AFTER THE SURGERY (TUMEFACTION OF THE SCAR + WHITISH LEAK). TREATMENT BY LOCAL CARE. THE TEAM HAS TRIED OTHER THREADS, MORE THINNER, BUT SAME PROBLEM. THE CUSTOMER DOES NOT KNOW THE REFERENCES INVOLVED IN EACH PATIENT, TWO POSSIBLE PRODUCT REFERENCES INVOLVED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945828 MONOSYN UNDYED 5/0 OR 6/0 SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2023613 OR C0023602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention