BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 19240338 · Received May 3, 2024

    Report

    Report Number
    2210968-2024-05110
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 9, 2023
    Report Date
    May 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-05109. CITATIONS :JOURNAL OF ORTHOPAEDICS. VOL. 39. PAGES: 70¿74. HTTPS://DOI.ORG/10.1016/J.JOR.2023.04.004.

    Description of Event or Problem · 0

    TITLE : DOUBLE ROW RECONSTRUCTION OF ACHILLES TENDON (SPEEDBRIDGE TECHNIQUE) FOR HAGLUND SYNDROME RESULTS IN EARLY WEIGHT BEARING. THE PRIMARY AIM OF THE PRESENT STUDY IS TO EVALUATE THE POSSIBILITY OF EARLY POSTOPERATIVE MOBILIZATION AND SECONDARILY, TO DETERMINE CLINICAL AND FUNCTIONAL OUTCOME FOLLOWING SPEEDBRIDGE TECHNIQUE OF RECONSTRUCTION OF ACHILLES TENDON FOLLOWING EXCISION OF HAGLUND DEFORMITY. THIS WAS A PROSPECTIVE OBSERVATIONAL STUDY PERFORMED BETWEEN JANUARY 2018 TO FEBRUARY 2019. ALL THE PATIENTS UNDERWENT OPEN EXCISION OF HAGLUND DEFORMITY AFTER COMPLETE DETACHMENT OF TA TENDON. THERE WERE 11 FEMALE AND 2 MALE PATIENTS (16 FEET) WITH MEAN AGE OF 53.00 ± 4.93 YEARS WERE ANALYZED. PARATENON SHEATH WAS CLOSED WITH CONTINUOUS 3.0 VICRYL PLUS (ETHICON VCP 936). SKIN WAS CLOSED USING 3.0 MONOFILAMENT NONABSORBABLE SUTURE (ETHILON NW 3328). ANKLE WAS KEPT IN NEUTRAL POSITION IN BELOW KNEE SLAB FOR 7 DAYS. THE REPORTED COMPLICATION INCLUDED SUPERFICIAL SURGICAL SITE INFECTION (N=2). IN CONCLUSION, HAGLUND DEFORMITY EXCISION AND RECONSTRUCTION OF TENDOACHILLES USING DOUBLE ROW TECHNIQUE IS AN AGILE CONSTRUCT FOR EARLY MOBILIZATION WITH AN EXCELLENT CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140832 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention