BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSYM PDS+ UNI VIO 18IN 1 SA CTX

    MDR report key: 20352702 · Received October 2, 2024

    Report

    Report Number
    2210968-2024-10469
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    August 9, 2023
    Report Date
    October 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031219366
    PMA / PMN Number
    K113004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. CITATION: SCIENCE TECHNOLOGY AND ENGINEERING 2023, 23 (32): 13741-06.

    Description of Event or Problem · 0

    TITLE: ENHANCED RECOVERY AFTER TOTAL KNEE REPLACEMENT: APPLICATION OF CONTINUOUS SUTURING OF ONE-WAY BARBED SUTURES AND CONTINUOUS LOCK SUTURING OF ABSORBABLE SUTURES THE STUDY AIMS TO INVESTIGATE THE CLINICAL EFFECT OF UNIDIRECTIONAL BARBED CONTINUOUS SUTURE AND CONTINUOUS EDGE STITCHING WITH ABSORBABLE THREAD IN ACCELERATED REHABILITATION OF TOTAL KNEE ARTHROPLASTY. FROM MARCH 2020 TO JUNE 2022, 106 PATIENTS WHO RECEIVED TOTAL KNEE ARTHROPLASTY WERE INCLUDED IN THE STUDY. 54 PATIENTS WERE INCLUDED IN OBSERVATION GROUP (ONE-WAY BARBED SUTURE CONTINUOUS SUTURE GROUP) AND 52 PATIENTS WERE INCLUDED IN CONTROL GROUP (ABSORBABLE SUTURE CONTINUOUS LOCKING SUTURE GROUP). IN THE OBSERVATION GROUP THERE WERE 16 MALES AND 38 FEMALES WITH A MEAN AGE OF 64.0 ± 6.3 YEARS AND A MEAN BMI OF 25.6 ± 3.6 KG/M2. IN THE CONTROL GROUP, THERE WERE 11 MALES AND 41 FEMALES WITH A MEAN AGE OF 25.6 ± 3.6 YEARS AND A MEAN BMI OF 25.7 ± 3.7 KG/M2. ALL PATIENTS WERE TREATED WITH A COMPETITOR¿S POSTERIOR STABILIZED KNEE CLOSURE PROSTHESIS (MANUFACTURER: SMITHAMPNEPHEW )THROUGH THE MEDIAL PARAPATELLAR APPROACH USING AN ANTERIOR MIDLINE KNEE INCISION. THE PROSTHESIS WAS INSTALLED, THE JOINT CAPSULE WAS SUTURED AT 60 ° OF KNEE FLEXION, AND 3-0 ABSORBABLE SUTURE (ETHICON VICRYL PLUS SUTURE VCP359, USA) WAS USED FOR CONTINUOUS LOCKING STITCH IN THE CONTROL GROUP. IN THE OBSERVATION GROUP, UNIDIRECTIONAL CONTINUOUS SEWING WITH AN ABSORBABLE MONOFILAMENT BARBED SUTURE (ETHICON ABSORBABLE SURGICAL SUTURE SXPP1A400, USA) IS APPLIED FROM THE DISTAL END OF INCISION TO THE INCISION, FOLLOWED BY 3-4 STITCHES, WITH MODERATE TIGHTNESS. IN THE TWO GROUPS, NON-ETHICON 2-0 ABSORBABLE SUTURE (MANUFACTURER: UNKNOWN) WAS USED FOR SIMPLE INTERRUPTED SUTURE OF SUBCUTANEOUS LAYER, AND NON-ETHICON DISPOSABLE SKIN STAPLER MANUFACTURER: UNKNOWN) WAS USED FOR SKIN SUTURE. REPORTED COMPLICATIONS INCLUDED SUBCUTANEOUS ECCHYMOSIS (N=9), NEEDLE STICK INJURY (N=10), INCISION REDNESS AND SWELLING (N=3), INCISION INFECTION (N=2), AND DELAYED INCISION HEALING (N=3). IN CONCLUSION, ALTHOUGH AFTER SURGERY THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 SUTURE METHODS IN TERMS OF EARLY REHABILITATION, RANGE OF MOTION OF KNEE JOINT AND FUNCTIONAL RECOVERY. HOWEVER, THE USE OF UNIDIRECTIONAL BARBED SUTURE FOR CONTINUOUS SUTURE DURING OPERATION COULD SHORTEN INTRAOPERATIVE SUTURE TIME, IMPROVE WATER TIGHTNESS, REDUCE POSTOPERATIVE SUBCUTANEOUS ECCHYMOSIS AND REDUCE THE PROBABILITY OF POSTOPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34765 SFXSYM PDS+ UNI VIO 18IN 1 SA CTX SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. 10705031219366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other