BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9503345 · Received December 20, 2019

    Report

    Report Number
    2210968-2019-91158
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 3, 2019
    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. CITATION: THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 37, NO. 2; DOL: 10.1177/0363546508324312. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: PERIANCHOR RADIOLUCENCY AFTER KNOTLESS ANCHOR REPAIR FOR SHOULDER INSTABILITY: CORRELATION WITH CLINICAL RESULTS OF 69 CASES." AUTHOR : JIN-YOUNG PARK,* MD, PHD, SANG-HOON LHEE,*^ MD, HONG-KEUN PARK,* MD, SUK HA JEON,* MD, AND JUNG HWAN OH,* MD, PHD. CITATION: THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 37, NO. 2; DOL: 10.1177/0363546508324312. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO INQUIRE INTO THE CLINICAL RESULT OF THE KNOTLESS METAL SUTURE ANCHOR TECHNIQUE AND TO CORRELATE THE RESULTS WITH RADIOLOGIC FINDINGS. FROM FEBRUARY 2001 TO JUNE 2005, 69 CONSECUTIVE PATIENTS (N=57 MEN AND N=12 WOMEN, MEAN AGE: 26 YEARS, AGE RANGE: 17-51 YEARS) WERE SELECTED ON THE BASIS OF THE CRITERIA AND UNDERWENT ARTHROSCOPIC BANKART REPAIR WITH THE KNOTLESS SUTURE ANCHOR. AN ANCHOR LOOP, WHICH CONSISTED OF NO. 1 ETHIBOND (ETHICON), WAS CAUGHT IN THE CHANNEL AT THE ANCHOR TIP AND TAPPED INTO A GLENOID PUNCHED HOLE TO 3-MM DEPTH, AND THE ANCHOR LOOP WAS EQUALLY ADJUSTED. COMPLAINT INCLUDED RE-DISLOCATION (N=1) AND WAS RE-OPERATED. ARTHROSCOPIC EXAMINATION SHOWED A DETACHED LABRUM. THE ANCHOR WAS FIRMLY INSERTED WITHOUT LOOSENING. ANOTHER COMPLAINT OF ANCHOR ARTHROPATHY CASES (N=2) AND BOTH UNDERWENT REOPERATION. BY ARTHROSCOPIC EXAMINATION, ANCHOR PROTRUSIONS WERE IDENTIFIED, AND ARTHROSCOPIC ANCHOR REMOVALS WERE PERFORMED. IN CONCLUSION, AFTER BANKART REPAIR USING KNOTLESS SUTURE ANCHOR, THE OMINOUS SIGN IS A WARNING SIGN FOR POSSIBLE FORTHCOMING COMPLICATIONS INCLUDING RE-DISLOCATION, ANCHOR ARTHROPATHY, AND RESIDUAL INSTABILITY. PATIENTS WITH THIS SIGN SHOULD BE EXAMINED FREQUENTLY WITH EXTREME CAUTION, INCLUDING ATTENTION TO THE RADIOLOGIC FINDING OF OSTEOPHYTE OF THE HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297987 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention