BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 23006695 · Received September 9, 2025

    Report

    Report Number
    2210968-2025-10253
    Event Type
    Injury
    Date Received
    September 9, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: HTTPS://DOI.ORG/10.20184/J.CNKI.ISSN1005-8478.100590 PLEASE SEE ARTICLE ATTACHED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: ZHANG'S TENSION-REDUCED SUTURE FOR HIGH TENSION INCISION FOR PILON FRACTURE THE AIM OF THIS STUDY IS TO INTRODUCE THE SURGICAL TECHNIQUE AND PRELIMINARY CLINICAL OUTCOMES OF ZHANG'S TENSION-REDUCED SUTURES FOR HIGH-TENSION INCISION SECONDARY TO OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF PILON FRACTURE. BETWEEN 2019 TO 2022, A TOTAL OF 11 PATIENTS HAD INCISIONS CLOSED BY TENSION-REDUCED SUTURE FOLLOWING ORIF (OPEN REDUCTION AND INTERNAL FIXATION) USING 2-0 VICRYL ABSORBABLE SUTURE (VICRYL RAPIDE, JOHNSON & JOHNSON). REPORTED COMPLICATIONS ARE: N=1; POOR INCISION HEALING TREATMENT: SECONDARY EXPANSION IN CONCLUSION, FOR THE HIGH-TENSION INCISION SUTURE OF PILON FRACTURE, THE METHOD OF ZHANG'S SUPER-TENSION SUTURE IS EASY TO OPERATE, EASY TO MASTER, WITH RELIABLE EFFECT, WHICH CAN WELL REALIZE THE PRIMARY CLOSURE OF INCISION, CONFORMING TO THE CONCEPT OF ERAS, WITHOUT THE NEED FOR A SECOND OPERATION AND SPECIAL CONSUMABLES, ACHIEVING A GOOD CLINICAL EFFICACY. IT IS WORTHY OF BEING WIDELY POPULARIZED IN THE CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842737 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention