BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED UNKNOWN PRODUCT

    MDR report key: 19321296 · Received May 15, 2024

    Report

    Report Number
    2210968-2024-05382
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    March 10, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (STRATAFIX SYMMETRIC PDS PLUS, STRATAFIX SPIRAL PDS PLUS, STRATAFIX SPIRAL MONOCRYL PLUS, MONOCRYL PLUS, VICRYL PLUS SUTURE, DERMABOND ADVANCED) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS CELLULITIS, DELAYED WOUND HEALING, TRAUMATIC DEHISCENCE, HIP DISLOCATION, RECURRENT JOINT EFFUSION, ARTHROCENTESIS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (STRATAFIX SYMMETRIC PDS PLUS, STRATAFIX SPIRAL PDS PLUS, STRATAFIX SPIRAL MONOCRYL PLUS, MONOCRYL PLUS, VICRYL PLUS SUTURE, DERMABOND ADVANCED) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (STRATAFIX SYMMETRIC PDS PLUS, STRATAFIX SPIRAL PDS PLUS, STRATAFIX SPIRAL MONOCRYL PLUS, MONOCRYL PLUS, VICRYL PLUS SUTURE, DERMABOND ADVANCED) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY: PAGES 1-6. HTTPS://DOI.ORG/10.1007/S00402-024-05283-9. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE : KNOTLESS SUTURE IN REVISION TOTAL JOINT ARTHROPLASTY: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. THE AIM OF THIS RANDOMIZED CONTROL TRIAL WAS TO ASSESS THE EFFICACY AND SAFETY OF BARBED SUTURE CLOSURE IN THE REVISION TJA SETTING. WE HYPOTHESIZE THAT BARBED SUTURES WILL SPEED TIME OF CLOSURE WITHOUT INCREASING THE RISK OF ADVERSE EVENTS, AND WOUND COMPLICATIONS. A TOTAL OF 80 PATIENTS UNDERGOING REVISION TJA BETWEEN SEPTEMBER 2020 AND NOVEMBER 2022 WERE INCLUDED IN THIS RANDOMIZED CONTROLLED TRIAL STUDY. PATIENTS RANDOMIZED TO THE TREATMENT ARM UNDERWENT REVISION TKA SURGERY UTILIZING UNINTERRUPTED 1 STRATAFIX SYMMETRIC PDS PLUS (ETHICON, SOMERVILLE, NEW-JERSEY) FOR CLOSURE OF THE ARTHROTOMY AND UNINTERRUPTED 2 - 0 STRATAFIX SPIRAL PDS PLUS (ETHICON, SOMERVILLE, NEW-JERSEY) FOR THE INTERMEDIATE LAYER. SUBCUTICULAR CLOSURE UTILIZED UNINTERRUPTED 3 - 0 STRATAFIX SPIRAL MONOCRYL PLUS SUTURE (ETHICON, SOMERVILLE, NEW-JERSEY) AND DERMABOND ADVANCED ADHESIVE (ETHICON, SOMERVILLE, NEW-JERSEY). FOR REVISION THA PATIENTS RANDOMIZED TO THE TREATMENT ARM, THE CAPSULE AND FASCIA WERE CLOSED USING UNINTERRUPTED 1 STRATAFIX SYMMETRIC PDS PLUS (ETHICON, SOMERVILLE, NEW- JERSEY). THE SUBDERMAL LAYER WAS CLOSED WITH UNINTERRUPTED 2-0 STRATAFIX SPIRAL PDS PLUS SUTURE (ETHICON, SOMERVILLE, NEW-JERSEY) AND THE SUBCUTICULAR LAYER WAS CLOSED WITH 3-0 STRATAFIX SPIRAL MONOCRYL PLUS (ETHICON, SOMERVILLE, NEW-JERSEY) AND DERMABOND ADVANCED (ETHICON, SOMERVILLE, NEW-JERSEY). THE REVISION THA CONTROL ARM UTILIZED INTERRUPTED FIGURE OF EIGHT 1-0 VICRYL PLUS SUTURE (ETHICON, SOMERVILLE, NEW-JERSEY) FOR THE JOINT CAPSULE AND DEEP FASCIAL LAYERS. THE SUBDERMAL AND SUBCUTICULAR LAYERS WERE CLOSED WITH SIMPLE INTERRUPTED 2-0 VICRYL PLUS AND 3-0MONOCRYL PLUS (ETHICON, SOMERVILLE, NEW-JERSEY) WITH DERMABOND ADVANCED (ETHICON, SOMERVILLE, NEW-JERSEY), RESPECTIVELY. THE REPORTED COMPLICATIONS INCLUDED CELLULITIS (N=2), DELAYED WOUND HEALING (N=1), TRAUMATIC DEHISCENCE (N=1),HIP DISLOCATION (N=1)AND RECURRENT JOINT EFFUSION (N=3). IN CONCLUSION, CLOSURE OF REVISION TJA SURGICAL WOUND UTILIZING BARBED SUTURES REDUCED CLOSURE TIME AND THE NUMBER OF NEEDLES HANDLED BY OPERATIVE STAFF, WITH NO SIGNIFICANT INCREASE IN INTRA- OR POST-OPERATIVE COMPLICATIONS RATE WHEN COMPARED TO TRADITIONAL CLOSURE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330756 DERMABOND ADVANCED UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other