BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 19214890 · Received April 30, 2024

    Report

    Report Number
    2210968-2024-04990
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    September 30, 2022
    Report Date
    April 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(6) 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: INDIAN JOURNAL OF ORTHOPAEDICS (2022); 56:2153¿2159. HTTPS://DOI.ORG/10.1007/S43465-022-00740-2.

    Description of Event or Problem · 0

    TITLE: PROXIMAL HUMERUS FRACTURES TREATED USING LOCKING PLATE: A COMPARISON BETWEEN ANATOMICAL REDUCTION AND VALGUS BENT LOCKING PLATE FIXATION AFTER VALGUS REDUCTION. THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE EFFICACY OF VALGUS REDUCTION AND BENT LOCKING PLATE FIXATION BY COMPARING SHORT-TERM FUNCTIONAL, CLINICAL, AND RADIOLOGIC OUTCOMES IN PATIENTS WITH PHFS WHO WERE TREATED WITH EITHER VALGUS BENT LOCKING PLATE FIXATION OR CONVENTIONAL LOCKING PLATE FIXATION. BETWEEN MARCH 2014 AND JULY 2019, A TOTAL OF 58 PATIENTS WITH PROXIMAL HUMERUS FRACTURES (PHFS) WHO WERE TREATED WITH LOCKING PLATE FIXATION WERE INCLUDED IN THE STUDY. THEY WERE DIVIDED INTO THE VALGUS-ALIGNED GROUP (N=28; 7 MALE AND 21 FEMALE; MEAN AGE OF 68.0 ± 13.1 YEARS) AND THE ANATOMICAL GROUP (N=30; 7 MALE AND 23 FEMALE; MEAN AGE OF 63.5 ± 15.3 YEARS). DURING THE SURGERY, ONCE THE FRACTURES WERE ADEQUATELY EXPOSED, HORIZONTAL MATTRESS SUTURES (ETHIBOND #2¿0; ETHICON®, PUERTO RICO, MEXICO) WERE USED AROUND THE GREATER AND THE LESSER TUBEROSITIES AT THE BONE¿TENDON JUNCTIONS TO MANIPULATE AND REDUCE THE TUBEROSITY AND HUMERAL HEAD FRAGMENTS. THE AVERAGE FOLLOW-UP PERIOD WAS 22.0 MONTHS (RANGE 12¿52 MONTHS). REPORTED COMPLICATIONS INCLUDE NONUNION OF THE GREATER TUBEROSITY AND REDUCTION LOSS (N=1) AND DEEP INFECTION (N=1). IN CONCLUSION, THE APPROPRIATE VALGUS REDUCTION AND VALGUS BENDING PLATE FIXATION COULD LEAD TO BETTER SHORT-TERM RESULTS AND IMPROVE THE ABILITY OF PROXIMAL HUMERUS LOCKING PLATES TO PREVENT VARUS COLLAPSE AND FIXATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147713 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention