BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9267837 · Received November 1, 2019

    Report

    Report Number
    2210968-2019-89398
    Event Type
    Injury
    Date Received
    November 1, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. SECOND DEVICE LOOSE REPORTED IN MW 2210968-2019-89394. CITATION: ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY (2006); 22(12): 1276-1282. DOI: DOI:10.]016/FANHRO.2006.07.005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: CLINICAL RESULTS OF ARTHROSCOPIC BANKART REPAIR WITH KNOT-TYING AND KNOTLESS SUTURE ANCHORS" AUTHORS: NAM SU CHO, M.D., ANDRI M. T. LUBIS, IVI.D., JEONG HAN HA, IVI.D., AND YONG GIRL RHEE, M.D. CITATION: ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY (2006); 22(12): 1276-1282. DOI: DOI:10.]016/FANHRO.2006.07.005. THE AIM OF THIS STUDY IS TO COMPARE THE RESULTS OF ARTHROSCOPIC BANKART REPAIR COMPLETED WITH KNOT-TYING WITH RESULTS OF THE PROCEDURE PERFORMED WITH KNOTLESS SUTURE ANCHORS. THIS RETROSPECTIVE STUDY INVOLVES 82 PATIENTS (75 MALE AND 7 FEMALE; MEAN AGE: 24 YEARS; AGE RANGE: 16 TO 42 YEARS) WHO UNDERWENT ARTHROSCOPIC BANKART REPAIR WITH THE USE OF KNOT TYING SUTURE ANCHORS OR KNOTLESS SUTURE ANCHORS BETWEEN AUGUST 2001 AND SEPTEMBER 2002. A TOTAL OF 61 PATIENTS WERE TREATED WITH KNOT-TYING SUTURE ANCHORS, AND 21 PATIENTS WERE TREATED WITH KNOTLESS SUTURE ANCHORS WHICH CONSIST OF A METAL BODY WITH 2 PRONGS AND AN ATTACHED, CLOSED "ANCHOR" LOOP OF BRAIDED METAL. A LONGER, OPEN "UTILITY" SUTURE LOOP (NO. 2 ETHIBOND; ETHICON) LINKED TO THE ANCHOR LOOP AND WAS USED TO PULL THE ANCHOR LOOP THROUGH THE TORN LABRUM TO BE REPAIRED. REPORTED COMPLICATION IN THE KNOTLESS SUTURE ANCHORS GROUP INCLUDED REDISLOCATION (N-1). PATIENT 1, A (B)(6) MALE PATIENT WHO HAD 5 REDISLOCATION AND RETEAR OF THE REPAIRED LABRUM AND UNDERWENT OPEN REVISION BANKART REPAIR. PATIENT 2, A (B)(6) MALE PATIENT WHO HAD 6 REDISLOCATION WITH 2 KNOTLESS SUTURE WERE LOOSE AND THE BANKART LESION HAD BEEN RETORN BY THE ALPSA LESION. OPEN REVISION BANKART REPAIR PATIENT 4, A (B)(6) MALE PATIENT WHO HAD 15 REDISLOCATION AND RETEAR OF THE LESION UNDERWENT OPEN REVISION BANKART SURGERY AND ROTATOR INVETERVAL CLOSURE AND COMPLETED CAPSULAR IMBRICATION. ALL PATIENTS NO LONGER REPORTED REDISLOCATION AFTER REVISION SURGERY WAS PERFORMED. IN CONCLUSION, THE KNOT-TYING AND KNOTLESS SUTURE ANCHOR GROUPS SHOWED IMPROVEMENT IN POSTOPERADVE SHOULDER SCORES AFTER ARTHROSCOPIC BANKART REPAIR. HOWEVER, RESULTS AFTER THE KNOTLESS TECHNIQUE WAS PERFORMED WERE UNSATISFACTORY WHEN COMPARED WITH RESULTS IN THE STANDARD SUTURE ANCHOR GROUP, PARTICULARLY IN TERMS OF REDISLOCATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060763 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention