BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7782776 · Received August 14, 2018

    Report

    Report Number
    2210968-2018-75148
    Event Type
    Injury
    Date Received
    August 14, 2018
    Report Date
    July 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: ARCH ORTHOP TRAUMA SURG (2016) 136:285¿293; DOI 10.1007/S00402-015-2362-Z.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : EARLY PASSIVE MOVEMENT IN FLEXOR TENDON INJURIES OF THE HAND". AUTHOR: S. QUADLBAUER1, CH. PEZZE, J. JURKOWITSCH, P. REB, T. BEER, M. LEIXNERING. CITATION: ARCH ORTHOP TRAUMA SURG (2016) 136:285¿293; DOI 10.1007/S00402-015-2362-Z. THE MAIN AIM OF THIS STUDY WAS TO RETROSPECTIVELY INVESTIGATE THE OUTCOME AFTER REPAIR OF ACUTE FLEXOR TENDON INJURIES FOLLOWED BY IMMEDIATE PHYSIOTHERAPY FROM THE FIRST POSTOPERATIVE DAY ACCORDING TO THE VIENNESE FLEXOR TENDON REHABILITATION PROGRAMME. FROM 2007 TO 2009, 115 FLEXOR TENDON INJURIES (N=69% MALE AND 31% FEMALE; PREDOMINANT AGE OF 38 YEARS [SD OF (B)(6) YEARS]) WERE RETROSPECTIVELY ANALYZED (N=20 THUMB INVOLVEMENT AND N=95 THREE-MEMBERED FINGERS INVOLVEMENT). ALL FLEXOR TENDONS WERE SUTURED USING TWO-STRAND REPAIR TECHNIQUE. IN THE PROCEDURE, THE FLEXOR TENDON WAS SUTURED WITH A DOUBLE THREADED 3.0 ETHIBOND EXCEL SUTURE AND THE PERITENDINOUS SHEATH WAS SEWN WITH A CONTINUOUS CIRCULAR SUTURE TECHNIQUE USING A 6.0 ETHIBOND EXCEL SUTURE. COMPLICATIONS INCLUDED TENDON RUPTURE (N=1), TENOLYSIS/ADHESION FORMATION (N=2) AND INFECTION (N=1). TO DATE IT IS NOT PROVEN IF AN INCREASE IN CORE SUTURES LEADS TO A BETTER CLINICAL OUTCOME OUTSIDE OF THE LABORATORY. THIS STUDY WAS ABLE TO SHOW THAT THE PRIMARY TWO-STRAND SUTURE ACCORDING TO ZECHNER COMBINED WITH IMMEDIATE POSTOPERATIVE PHYSIOTHERAPY IN TERMS OF AN ¿EARLY PASSIVE MOVEMENT¿ ACHIEVED AN EXCELLENT CLINICAL OUTCOME AND A LOW COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624210 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention