BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 16662350 · Received April 3, 2023

    Report

    Report Number
    2210968-2023-02296
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    September 25, 2021
    Report Date
    April 3, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. SHOULD FURTHER DETAILS BE PROVIDED, THE FILE WILL BE UPDATED ACCORDINGLY. 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INTJ ORTHOP, SEP. 25, 2021; 42(5):319-322.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF THE THERAPEUTIC EFFECTS OF STAPLING AND SUTURING IN CALCANEAL SKIN INCISION. THE AIM OF THIS STUDY WAS TO COMPARE THE EFFICACY OF STAPLING AND SUTURE IN CLOSING THE INCISION OF CALCANEAL FRACTURES. FROM JANUARY 2018 TO JANUARY 2020, A TOTAL OF 96 PATIENTS (54 MALE AND 42 FEMALE) WITH CALCANEAL FRACTURE WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMLY DIVIDED INTO 2 GROUPS ACCORDING TO SKIN CLOSURE METHOD: GROUP A (STAPLING GROUP: N=48; 29 MALE AND 19 FEMALE; MEAN AGE WAS 31.42 ± 7. 65 YEARS) USING A DISPOSABLE SKIN SEWING MACHINE (HERAEUS CHANGZHOU PWH-W35) TO PIN THE CUTOUTS, AND GROUP B (SUTURE GROUP: N=48; 25 MALE AND 23 FEMALE; MEAN AGE WAS 30.71 ± 6.54 YEARS) USING A JOHNSON & JOHNSON NORMAL 1# SILK SUTURE TO SEWING THE CUTOUTS. REPORTED COMPLICATIONS INCLUDE NECROSIS OF THE CORTEX (N=8), INFLAMMATORY REACTION (N=7), CUT OUT CRACKING (N=4), INCISION INFECTION (N=3), AND CENTIPEDE SCAR (N=15). IN CONCLUSION, THE DISPOSABLE SKIN SEWING MACHINE KNITTING AND BONE FRACTURE HAND PROCEDURE CLOSES THE SKIN INCISION MORE QUICKLY, THE RATE OF NECROSIS OF THE CORTEX IS LOWER, AND THE SEVERITY OF PAIN WHEN THE NAIL IS REMOVED IS LESS. THE LOW INCIDENCE OF "CENTIPEDE" SCAR CAN SHORTEN THE PROCEDURE TIME, REDUCE THE INCIDENCE OF SURGICAL COMPLICATIONS, AND REDUCE PATIENT PAIN. AND CAN ACHIEVE BETTER BEAUTY EFFECT, HAS A LARGE APPLICATION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265454 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other HERAEUS CHANGZHOU PWH-W35