BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22169279 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06509
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    March 2, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J CLIN MED. 2025 MAR 2;14(5):1683. DOI: 10.3390/JCM14051683. PMID: 40095680; PMCID: PMC11899996. HTTPS://DOI.ORG/10.3390/JCM14051683.

    Description of Event or Problem · 0

    THE MODIFIED BROSTRÖM PROCEDURE WITH SUTURE-TAPE AUGMENTATION FOR CHRONIC LATERAL ANKLE INSTABILITY. THE AIM OF THIS STUDY IS TO EVALUATE THE INTERMEDIATE-TERM CLINICAL OUTCOMES AFTER THE MODIFIED BROSTRÖM PROCEDURE (MBP) WITH SUTURE-TAPE AUGMENTATION FOR CHRONIC LATERAL ANKLE INSTABILITY. BETWEEN OCTOBER 2017 AND NOVEMBER 2021, 94 PATIENTS (94 ANKLES) CONSECUTIVELY UNDERWENT THE MBP WITH SUTURE-TAPE AUGMENTATION FOR CHRONIC LATERAL ANKLE INSTABILITY WERE ANALYZED. THE INCLUSION CRITERIA FOR THIS STUDY WERE AS FOLLOWS: (1) UNILATERAL ANKLE INSTABILITY, (2) NO ADVANCED OSTEOCHONDRAL LESION NEEDING MICROFRACTURE OR AUTOLOGOUS OSTEOCHONDRAL TRANSPLANTATION, AND (3) NO PREVIOUS ANKLE LIGAMENT SURGERY HISTORY. WITH CONSIDERATION FOR HETEROGENEITY IN DETAILS OF THE SURGICAL TECHNIQUE (RANGE OF SKIN INCISION, NUMBER AND INGREDIENT OF REMAINING SUTURE ANCHORS, INSERTION POINT OF SUTURE ANCHORS, USE OF THE CALCANEOFIBULAR LIGAMENT OR INFERIOR EXTENSOR RETINACULUM, ETC.) AND REMNANT LIGAMENTOUS TISSUE CONDITION (PRESENCE OF IATROGENIC SCAR TISSUE ADHESION AND REMAINED SUTURE MATERIALS), WE DETERMINED A HISTORY OF PREVIOUS ANKLE LIGAMENT SURGERY AS ONE OF THE EXCLUSION CRITERIA. IN THIS STUDY, 3 PATIENTS WITH BILATERAL ANKLE INSTABILITY, 6 PATIENTS WITH CONCOMITANT MICROFRACTURE OR OSTEOCHONDRAL TRANSPLANTATION, AND 11 PATIENTS WITH PREVIOUS ANKLE LIGAMENT SURGERY WERE EXCLUDED. IN ADDITION, ONE PATIENT WAS UNWILLING TO PARTICIPATE AND WAS EXCLUDED FROM THIS STUDY. THE MEAN AGE OF THE PATIENTS WAS 29.6 YEARS (RANGE, 19 TO 45 YEARS), AND THE MEAN DURATION OF SYMPTOMS WAS 40.2 MONTHS (RANGE, 8 TO 92 MONTHS). THIS STUDY INCLUDED 51 MALE AND 43 FEMALE PATIENTS. INFORMED CONSENT REGARDING THE PROMISED VISIT FREQUENCY AND EXAMINATION CONTENT AFTER SURGERY WAS GIVEN TO ALL PARTICIPANTS. REPORTED COMPLICATION IS: - SKIN IRRITATION BY SUTURE MATERIALS (N=1) TREATMENT: UNDERWENT SUTURE (VICRYL) KNOT REMOVAL UNDER LOCAL ANESTHESIA AT 8 MONTHS POSTOPERATIVELY. IN CONCLUSION, THE MBP AUGMENTED WITH SUTURE TAPE APPEARS TO BE AN EFFECTIVE SURGICAL TECHNIQUE FOR CHRONIC LATERAL ANKLE INSTABILITY. THROUGH ANATOMIC REPAIR OF ATTENUATED ANKLE LIGAMENTS AND SUTURE-TAPE AUGMENTATION, THIS MODIFIED PROCEDURE CAN PROVIDE RELIABLE MECHANICAL STABILITY AND MINIMAL RISK OF RECURRENT INSTABILITY. IN ADDITION, STATIC AND DYNAMIC POSTURAL CONTROL ABILITY MAY BE IMPROVED THROUGH CONTINUOUS PROPRIOCEPTIVE-ORIENTED REHABILITATION FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344404 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention