BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19217090 · Received April 30, 2024

    Report

    Report Number
    2210968-2024-05004
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 1, 2023
    Report Date
    April 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 2210968-2024-05004 AND 2210968-2024-05005. CITATION: J ORTHOP TRAUMA (APRIL 2023); 37(4):E153¿E158. HTTPS://DOI.ORG/10.1097/BOT.0000000000002534.

    Description of Event or Problem · 0

    TITLE: THE ROUTINE USE OF RUNNING SUBCUTICULAR CLOSURES IN ORTHOPAEDIC TRAUMA PATIENTS DOES NOT INCREASE WOUND COMPLICATIONS. THE AIM OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE WHETHER THE ROUTINE USE OF RUNNING SUBCUTICULAR CLOSURES (RSC) IN ORTHOPAEDIC TRAUMA PATIENTS INCREASES THE RATE OF WOUND COMPLICATIONS AND REOPERATIONS. A TOTAL OF 266 PATIENTS (179 WERE MALES; MEDIAN AGE OF 45 YEARS; MEDIAN BMI WAS 25.9) UNDERGOING ORTHOPAEDIC TRAUMA PROCEDURES BETWEEN JUNE 2020 AND MARCH 2022 WERE INCLUDED IN THE STUDY. AFTER IRRIGATION WITH SALINE, FASCIAL LAYERS WERE CLOSED WITH 0-POLYDIOXANONE (PDS) (ETHICON, RARITAN, NJ) IN AN INTERRUPTED FIGURE-OF-EIGHT FASHION. DEEP DERMAL LAYERS WERE CLOSED WITH 2-0 MONOCRYL (ETHICON, RARITAN, NJ). BEFORE THE IMPLEMENTATION OF THE RSC PROTOCOL, SKIN WAS CLOSED USING METALLIC SURGICAL STAPLES OR A 2-0 NYLON HORIZONTAL CMC PER THE SURGEON¿S PREFERENCE (HISTORICAL CONTROL GROUP; N=133; 41 WERE FEMALES). AFTER THE ADOPTION OF THE RSC PROTOCOL, ALL PATIENTS RECEIVED RSC (N=133; 46 WERE FEMALES) WITH 3-0 MONOCRYL (ETHICON, RARITAN, NJ), TISSUE ADHESIVE (EXOFIN, CHEMENCE MEDICAL, ALPHARETTA, GA), AND STERI-STRIPS (3M, SAINT PAUL, MN), UNLESS THEIR WOUNDS WERE UNABLE TO BE APPROXIMATED WITH SUBCUTANEOUS 2-0 MONOFILAMENT SUTURE. PATIENTS WHO DID NOT RECEIVE RSC WERE CLOSED WITH METALLIC SURGICAL STAPLES OR A 2-0 NYLON HORIZONTAL CMC PER THE SURGEON¿S PREFERENCE. REPORTED COMPLICATIONS INCLUDE DELAYED WOUND HEALING (N=2), WOUND DEHISCENCE (N=4), SUPERFICIAL INFECTION (N=?), AND DEEP INFECTION (N=25). IN CONCLUSION, RSC FOR ORTHOPAEDIC TRAUMA PROCEDURES WAS NOT ASSOCIATED WITH INCREASED WOUND COMPLICATIONS WHEN COMPARED A HISTORICAL COHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171218 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other