BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 15402684 · Received September 12, 2022

    Report

    Report Number
    2210968-2022-07420
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    January 1, 2020
    Report Date
    September 12, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. (B)(4). CITATION: JOURNAL OF MEDICAL COLLEGE, 2020, 37 (2): 189.192. DOI: 10.7683/XXYX"B.2020.02.021

    Description of Event or Problem · 0

    TITLE: COMPARISON OF POLYESTER NON-ABSORBABLE SUTURE AND KIRSCHNER WIRE TENSION BAND INTERNAL FIXATION IN THE TREATMENT OF OLECRANON FRACTURE. THE OBJECTIVES OF THIS STUDY IS TO COMPARE THE CLINICAL EFFECTS OF POLYESTER NONABSORBABLE SUTURE AND KIRSCHNER WIRE TENSION BAND INTERNAL FIXATION IN THE TREATMENT OF OLECRANON FRACTURE. FROM JANUARY TO DECEMBER 2017, 45 PATIENTS WITH SIMPLE OLECRANON FRACTURE WERE ADMITTED TO NANYANG ORTHOPAEDIC HOSPITAL AS THE STUDY SUBJECTS, AND THE PATIENTS WERE DIVIDED INTO POLYESTER GROUP ACCORDING TO THE TREATMENT METHOD. POLYESTER NON-ABSORBABLE SUTURES (TRADE NAME: ETHICON) (GROUP A, N = 22) AND KIRSCHNER WIRE TENSION BAND GROUP (GROUP B, N = 23). GROUP A PATIENTS RECEIVED OLECRANON FIXATION WITH POLYESTER NONABSORBABLE SUTURE. REPORTED COMPLICATION INCLUDED FRACTURE END SEPARATION AND INTERNAL FIXATION FAILURE OCCURRED IN CONCLUSION POLYESTER NON-ABSORBABLE SUTURE AND KIRSCHNER WIRE TENSION BAND INTERNAL FIXATION ARE EFFECTIVE IN THE TREATMENT OF MAYO TYPE IA, IB AND IIA OLECRANON FRACTURES, BUT POLYESTER SUTURE IN THE TREATMENT OF OLECRANON FRACTURE WITH ESTER NON-ABSORBABLE SUTURE INTERNAL FIXATION HAS THE ADVANTAGES OF SIMPLER OPERATION METHOD, NO LOCAL SOFT TISSUE IRRITATION SIGN CAUSED BY INTERNAL FIXATION PROTRUSION, AND NO NEED A SECOND OPERATION TO REMOVE THE INTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820343 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention