BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12492730 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08640
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 24, 2021
    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 · 1

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO CLARIFY 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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (SOFT TISSUE IRRITATION (N=1)) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE) USED FOR CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE A COMPLETE PATIENT DEMOGRAPHICS FOR PATIENTS WITH POST-OP COMPLICATIONS (SOFT TISSUE IRRITATION (N=1))? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. COULD YOU PLEASE SPECIFY/CLARIFY WHAT WERE CONTRIBUTING FACTORS/CAUSE OF K-WIRE MIGRATION AFTER HEALED FRACTURE IN ONE CASE IN SUTURE GROUP? CITATION: ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 107 (2021) 102798; HTTPS://DOI.ORG/10.1016/J.OTSR.2020.102798. 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 · 1

    TITLE: COMPARISON OF DOUBLE-STRAND BRAIDED POLYESTER SUTURES TENSION BAND (NICE KNOT) WITH CABLE TENSION BAND IN TRANSVERSE PATELLAR FRACTURES. THE AIM OF THIS STUDY IS TO COMPARE THE TENSION BAND TECHNIQUE WITH THE APPLICATION OF BRAIDED POLYESTER NONABSORBABLE SUTURES USING NICE KNOT TECHNIQUE AND TITANIUM CABLE. BETWEEN JULY 2018 AND JUNE 2019, A TOTAL OF 40 PATIENTS WITH TRANSVERSE PATELLAR FRACTURES PARTICIPATED IN THIS STUDY. OF THESE, 20 PATIENTS [10 MALE AND 10 FEMALE; MEAN AGE OF 47.55 YEARS (RANGE: 22 TO 71 YEARS)] UNDERWENT SUTURES TENSION BAND FIXATION (NICE KNOT; SUTURE GROUP) USING TWO NO. 5 ETHIBOND DOUBLE-STRAND BRAIDED POLYESTER SUTURES (ETHICON, SOMERVILLE, NJ), AND THE OTHER 20 PATIENTS [11 MALE AND 9 FEMALE; MEAN AGE OF 48.5 YEARS (RANGE: 26 TO 68 YEARS)] WERE MANAGED WITH CABLE TENSION BANDS (CABLE GROUP). ALL PATIENTS WERE FOLLOWED UP AT 1, 3, 6, AND 12 MONTHS. REPORTED COMPLICATIONS SOFT TISSUE IRRITATION DUE TO THE KNOT (N=1) WHICH WAS RESOLVED BY REMOVING THE KNOT USING A SMALL INCISION. IN CONCLUSION, THE SUTURE TENSION BAND TECHNIQUE USING BRAIDED POLYESTER NON-ABSORBABLE SUTURES TIED WITH NICE KNOT WAS AS EFFECTIVE AS THE CABLE TENSION BAND TECHNIQUE FOR TRANSVERSE PATELLAR FRACTURE MANAGEMENT. BASED ON OUR EXISTING DATA, MORE EASILY OPERATIONS, LOWER COSTS AND FEWER COMPLICATIONS WERE FOUND WITH THE SUTURE TECHNIQUE THAN WITH THE CABLE TECHNIQUE. THEREFORE, THIS PROCEDURE MAY BE A NEW OPTION FOR THE TREATMENT OF TRANSVERSE PATELLAR FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386194 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention