BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7854785 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75690
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. CITATION: J BONE JOINT SURG [BR]. 2009; 91-B: 201-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: LARGE AND MASSIVE TEARS OF THE ROTATOR CUFF" AUTHORS: B. C. HANUSCH, L. GOODCHILD, P. FINN, A. RANGAN CITATION: J BONE JOINT SURG [BR]. 2009; 91-B: 201-5. THE AIM OF THIS STUDY WAS TO DETERMINE THE FUNCTIONAL OUTCOME AND RATE OF RE-TEARS FOLLOWING MINI-OPEN REPAIR OF SYMPTOMATIC LARGE AND MASSIVE TEARS OF THE ROTATOR CUFF USING A TWO-ROW TECHNIQUE. A TOTAL OF 24 PATIENTS (12 MEN AND 12 WOMEN; AGE RANGE: 42 TO 74 YEARS OLD) WERE REVIEWED PROSPECTIVELY WITH A LARGE OR MASSIVE TEAR OF THE ROTATOR CUFF WHO HAD SURGICAL REPAIR BETWEEN 2002 AND 2006. DURING THE SURGICAL PROCEDURE, THE DELTOID WAS SPLIT IN THE LINE OF ITS FIBERS TO ALLOW DIRECT ACCESS TO THE TEAR. THE TENDONS WERE APPROXIMATED SIDE TO SIDE TO ACHIEVE MARGIN CONVERGENCE WITH SIMPLE MATTRESS SUTURES USING ETHIBOND 1-0 SUTURES (ETHICON). THE RECONSTRUCTED CUFF WAS FIXED TO THE BONY FOOTPRINT USING TWO ROWS OF ABSORBABLE PANALOK RC SUTURE ANCHORS WITH PANACRYL SUTURES (ETHICON). SIMPLE MATTRESS SUTURES WERE USED FOR THE MEDIAL ROW AND MODIFIED MASON-ALLEN SUTURES FOR THE LATERAL ROW. TWO TO THREE SUTURE ANCHORS WERE USED IN EACH OF THE ROWS. REPORTED COMPLICATION INCLUDED RE-RUPTURE IN WHICH THE SUPRASPINATUS TENDON HAD RETRACTED UNDER THE ACROMION (N-2) AND RE-RUPTURE WITH FULL-THICKNESS DEFECT WITHOUT RETRACTION (N-2). IT WAS REPORTED THAT THE BEST TREATMENT FOR LARGE AND MASSIVE TEARS OF THE ROTATOR CUFF REMAINS CONTROVERSIAL. IT IS WIDELY ACKNOWLEDGED THAT SURGICAL REPAIR OF SUCH TEARS SIGNIFICANTLY REDUCES PAIN AND IMPROVES SHOULDER FUNCTION, BUT THE SIZE OF THE TEAR AND THE POOR QUALITY OF THE TISSUES OFTEN MAKE SUCCESSFUL REPAIR DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696018 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PANALOK RC SUTURE ANCHORS