BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9503446 · Received December 20, 2019

    Report

    Report Number
    2210968-2019-91161
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 4, 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: J BONE JOINT SURG [BR] 2008;90-B:1341-7; DOI: 10.1302/0301 -620X.90B 10.19989 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: MID-TERM CLINICAL AND SONOGRAPHIC OUTCOME OF ARTHROSCOPIC REPAIR OF THE ROTATOR CUFF". AUTHOR : O. LEVY, B. VENKATESWARAN, T. EVEN, M. RAVENSCROFT, S. COPELAND. CITATION: J BONE JOINT SURG [BR] 2008;90-B:1341-7; DOI: 10.1302/0301 -620X.90B 10.19989. THE AIMED OF THIS PROSPECTIVE STUDY WAS TO ASSESS THE MID-TERM CLINICAL RESULTS FOLLOWING ARTHROSCOPIC REPAIR OF THE ROTATOR CUFF. BETWEEN OCTOBER 1998 AND MAY 2003, 102 PATIENTS(WOMEN=38, MEN=64; MEAN AGE=57.3 YEARS; AGE RANGE=23 ¿ 78 YEARS) UNDERWENT ARTHROSCOPIC REPAIR OF THE ROTATOR CUFF WERE EVALUATED. DURING THE PROCEDURE, FOR SMALL TO MEDIUM-SIZED C-SHAPED TEARS, THE REPAIR TECHNIQUES VARIED FROM A SIMPLE SINGLE- ROW TECHNIQUE WITH ONE OR TWO SUTURE ANCHORS TO THE ¿PARACHUTE TECHNIQUE¿. FOR L-SHAPED OR INVERTED L SHAPED TEARS, A SINGLE-ROW TECHNIQUE WITH TWO ANCHORS AND SIDE-TO-SIDE SUTURE REPAIR WAS USED. FOR LARGER TEARS, OR AFTER A REPAIR WITH THE PARACHUTE TECHNIQUE, WHERE THERE WAS A FLAP OF CUFF TISSUE LATERALLY, THEY USED A DOUBLE-ROW TECHNIQUE IN A ¿RATCHET-LOOP CONFIGURATION¿. ONE PAIR OF SUTURES IS USED FOR THE ANTERIOR LEAF OF THE TEAR, AND THE OTHER PAIR FOR THE POSTERIOR LEAF. A NUMBER OF DIFFERENT SUTURE ANCHORS WERE USED INCLUDING THE FASTIN RC WITH ETHIBOND SUTURES (ETHICON), BIOFASTIN RC WITH ETHIBOND SUTURES (ETHICON), WITH TWINFIX ULTRABRAID SUTURES AND THE SPIRALOCK WITH ORTHOCORD SUTURES. REPORTED COMPLICATIONS INCLUDED FRAYING AND DEGENERATION (N=7) IN WHICH 3 WERE TREATED BY TENOTOMY AND FOUR WERE TREATED WITH ARTHROSCOPIC TENODESIS; MILD FRAYING OF THE BICEPS TENDON (N=8); INSTABILITY OF THE BICEPS TENDON (N=5), IN WHICH 2 WERE TREATED BY TENOTOMY AND THREE WITH ARTHROSCOPIC TENODESIS; BICEPS TENDON WAS ABSENT OR FOUND TO BE TORN (N=14); SUBLUXED/DISLOCATED (N=5); RECURRENT ROTATOR CUFF TEARS (N=19). IN CONCLUSION, THIS STUDY STATED THAT ARTHROSCOPIC REPAIR OF THE ROTATOR CUFF LEADS TO HIGH RATES OF SATISFACTION AND GOOD FUNCTIONAL RESULTS, ALBEIT WITH A RECURRENCE RATE OF 18.6%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295957 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention