BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18832821 · Received March 4, 2024

    Report

    Report Number
    2210968-2024-02335
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 21, 2022
    Report Date
    March 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J HAND SURG AM. 2022;47(6):507-516. HTTPS://DOI.ORG/10.1016/J.JHSA.2022.01.021.

    Description of Event or Problem · 0

    TITLE: ARTHROSCOPIC-ASSISTED FOVEAL REATTACHMENT OF TRIANGULAR FIBROCARTILAGE COMPLEX TEARS WITH DISTAL RADIOULNAR JOINT INSTABILITY: A COMPARISON OF SUTURE ANCHORS AND TRANSOSSEOUS SUTURES. THE AIM OF THIS PROSPECTIVE, SINGLE-CENTER RANDOMIZED CONTROLLED TRIAL IS TO COMPARE THE CLINICAL OUTCOMES OF ARTHROSCOPICALLY-ASSISTED SUTURE ANCHOR REPAIR AND TRANSOSSEOUS SUTURES FOR REPAIR OF FOVEAL TRIANGULAR FIBROCARTILAGE COMPLEX TEARS IN PATIENTS WITH DISTAL RADIOULNAR JOINT (DRUJ) INSTABILITY. BETWEEN 2014 AND 2020, A TOTAL OF 60 PATIENTS WITH TRIANGULAR FIBROCARTILAGE COMPLEX FOVEAL DETACHMENT ASSOCIATED WITH DRUJ INSTABILITY WERE PROSPECTIVELY RECRUITED AND RANDOMIZED INTO 2 EQUAL GROUPS¿THE ANCHOR REPAIR GROUP (N=30; 20 MALE AND 10 FEMALE; MEAN AGE 31.8 ± 8.9 YEARS) AND THE TRANSOSSEOUS REPAIR GROUP (N=30; 15 MALE AND 15 FEMALE; MEAN AGE 30.2 ± 8.2 YEARS). IN THE ANCHOR REPAIR GROUP, COMPETITOR DEVICE WAS USED, WHILE IN THE TRANSOSSEOUS REPAIR GROUP, 2-0 AND 3-0 PROLENE SUTURE WAS USED. REPORTED COMPLICATIONS IN THE TRANSOSSEOUS REPAIR GROUP INCLUDE PAINFUL SCAR, A LIMITED RANGE OF PRONATION/SUPINATION, AND THE DRUJ WAS LESS STABLE THAN THE INTACT CONTRALATERAL SIDE LEADING TO POOR RESULT (N=1), AND PAINFUL SUBCUTANEOUS SUTURE KNOT REQUIRING A SECOND SURGERY FOR REMOVAL OF THE KNOT (N=5; 2 MEN AND 3 WOMEN). IN CONCLUSION, BOTH TECHNIQUES YIELDED GOOD AND COMPARABLE OUTCOMES WITH A LESSER INCIDENCE OF EARLY COMPLICATIONS IN THE ANCHOR REPAIR GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166409 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention