BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7810859 · Received August 23, 2018

    Report

    Report Number
    2210968-2018-75371
    Event Type
    Injury
    Date Received
    August 23, 2018
    Report Date
    August 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2016; 24: 1972 1978. DOI: 10.1007/S00167-014-3294-9 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "SURGICAL TREATMENT OF ACUTE ACROMIOCLAVICULAR JOINT DISLOCATIONS: HOOK PLATE VERSUS MINIMALLY INVASIVE RECONSTRUCTION". AUTHORS: S. METZLAFF · S. ROSSLENBROICH · P. H. FORKEL · B. SCHLIEMANN · H. ARSHAD · M. RASCHKE · W. PETERSEN. CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2016; 24: 1972 1978. DOI: 10.1007/S00167-014-3294-9. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICAL RESULTS OF A MINIMALLY INVASIVE TECHNIQUE FOR ACUTE ACROMIOCLAVICULAR (AC) JOINT DISLOCATION REPAIR WITH THE TRADITIONAL HOOK PLATE (HP) FIXATION. BETWEEN FEBRUARY 2007 AND JUNE 2011, A TOTAL OF 44 PATIENTS (35 MALE AND 9 FEMALE PATIENTS; AGE RANGE: 18 TO 56 YEARS OLD) UNDERWENT SURGICAL RECONSTRUCTION FOR AN ACUTE AC JOINT DISLOCATION TYPE III¿V ACCORDING TO ROCKWOOD¿S CLASSIFICATION. A TOTAL OF 20 PATIENTS WERE TREATED WITH HP FIXATION AND 24 PATIENTS UNDERWENT MINIMALLY INVASIVE AC JOINT RECONSTRUCTION. DURING THE SURGICAL PROCEDURE OF THE MINAR TECHNIQUE, 2 FLIP BUTTONS WERE THEN ASSEMBLED WITH A BRAIDED ETHIBOND 1-0 SUTURE (ETHICON). ONE OF THE BUTTONS WAS THEN GUIDED THROUGH THE CORACOID DRILL HOLE USING A SPECIFIC BUTTON PUSHER AND FLIPPED TO A HORIZONTAL POSITION. IN THE MINAR TECHNIQUE GROUP, REPORTED COMPLICATION INCLUDED LOSS OF REDUCTION DUE TO LOOSENING OF THE CLAVICULAR BUTTON (N-1) WHICH REQUIRED REVISION AND THE WOUND HEALING WAS WITHOUT ANY COMPLICATION AND POSTERIOR INSTABILITY (N-3). THE MINAR TECHNIQUE REPRESENTS A SAFE METHOD FOR AC JOINT RECONSTRUCTION IN ACUTE AC JOINT INSTABILITY AND YIELDS GOOD EARLY CLINICAL RESULTS COMPARABLE TO HP FIXATION DESPITE THE INCIDENCE OF PARTIAL RECURRENT VERTICAL AND HORIZONTAL INSTABILITY. IN CONTRAST TO HP FIXATION, A SECOND OPERATION FOR IMPLANT REMOVAL IS NOT REQUIRED AFTER MINAR..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651359 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention