BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8258776 · Received January 17, 2019

    Report

    Report Number
    2210968-2019-78477
    Event Type
    Injury
    Date Received
    January 17, 2019
    Report Date
    January 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: INJURY, INT. J. CARE INJURED 32 (2001) 129¿135. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: CLINICAL EXPERIENCE OF PATELLAR FRACTURE FIXATION USING METAL WIRE OR NON-ABSORBABLE POLYESTER ¿ A STUDY OF 37 CASES." AUTHORS: HARMINDER S. GOSAL , PARMINDER SINGH, RICHARD E. FIELD. CITATION: INJURY, INT. J. CARE INJURED 32 (2001) 129¿135. THIS STUDY AIMED TO PRESENT THE RESULTS OF PATELLAR FRACTURE FIXATION USING METAL WIRE AND NON-ABSORBABLE POLYESTER. OVER A 4-YEAR PERIOD, 37 PATIENTS (N=13 MALE AND N=24 FEMALE; AVERAGE AGE OF 64 YEARS AND 6 MONTHS) WITH PATELLAR FRACTURES WERE TREATED OPERATIVELY AND WERE ALLOCATED INTO TWO TREATMENT TECHNIQUES: GROUP 1 (N=21) BEING TREATED BY THE ¿AO¿ TECHNIQUE USING STAINLESS STEEL WIRE, AND THOSE IN GROUP 2 (N=16) HAVING THEIR PATELLAE FIXED USING 5 ETHIBOND SUTURE. POSTOPERATIVELY, A (B)(6)-YEAR-OLD MALE PATIENT WITH CLOSED COMMINUTED DISPLACED FRACTURE DUE TO FALL WHO UNDERWENT FIXATION USING ETHIBOND SUTURE HAD FRACTURE DISPLACED WHICH REQUIRED REOPERATION. AT REOPERATION, IT WAS FOUND THAT A KNOT IN THE POLYESTER SUTURE HAD BECOME UNDONE, AND THE FRACTURE WAS FIXED USING K-WIRES AND STAINLESS STEEL TENSION BAND WIRING. FOLLOWING THIS THE PATIENT MADE AN UNEVENTFUL RECOVERY. THIS STUDY IS THE FIRST TO REPORT THE RESULTS COMPARING NON-ABSORBABLE POLYESTER AND STAINLESS STEEL WIRE AS THE FIXATION MATERIALS. WE ROUTINELY BURY THE KNOT IN THE SOFT TISSUES AND WE HAVE NOT HAD TO RE-OPERATE TO REMOVE THE SUTURE MATERIAL. THE RELATIVE RISK OF RE-OPERATION IN THE METAL GROUP IS SIX TIMES THAT IN THE NON-ABSORBABLE POLYESTER GROUP. NON-ABSORBABLE POLYESTER APPEARS TO COMPARE FAVOURABLY WITH THE USE OF METALLIC WIRE TO FIX PATELLAR FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50567 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention