BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7823157 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75468
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND SUTURE) 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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY. 2013; 66: 1610 1612 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE:" THE JUNCTURA LASSO: CORRECTION OF EXTENSOR TENDON DISPLACEMENT" AUTHORS: CHIN CHEAN YONG A,*, CARA M. CONNOLLY B, MATT ERDMANN CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY. 2013; 66: 1610 1612 DOI: HTTP://DX.DOI.ORG/10.1016/J.BJPS.2013.01.032. RECURRENT VOLAR DISPLACEMENT OF THE EXTENSOR DIGITORUM COMMUNIS TENDON (EDC) AT THE METACARPOPHALANGEAL JOINT (MCPJ) MORE COMMONLY OCCURS POST-TRAUMA OR IN THE RHEUMATOID HAND. A (B)(6) MALE PATIENT SUFFERED CHRONIC PAINFUL VOLAR DISPLACEMENT OF THE EDC AT THE MCPJ OF HIS LEFT RING FINGER FOLLOWING VTH RAY AMPUTATION FOR SEVERE DUPUYTREN¿S DISEASE. DURING THE SURGICAL PROCEDURE, A ¿LASSO¿ WAS CREATED BY PASSING THE SLIP BENEATH THE IVTH EDC TENDON AND SECURING IT ONTO ITSELF WITH AN ETHICON 5-0 SUTURE (ETHICON). THE FINGER WAS THEN TAKEN THROUGH A FULL RANGE OF MOTION TO CONFIRM STABILITY OF THE EDC. THE TOURNIQUET WAS DEFLATED, HEMOSTASIS WAS ACHIEVED AND THE WOUND CLOSED. REPORTED COMPLICATION INCLUDED EARLY EPISODE OF WOUND INFECTION WHICH RESOLVED WITH ANTIBIOTICS. THIS RECONSTRUCTION WAS THEN TESTED IN ALL RANGES OF MCPJ FLEXION, SUCCESSFULLY PREVENTING VOLAR DISPLACEMENT OF THE EXTENSOR TENDON. IT WAS CONCLUDED THAT THE ¿LASSO¿ PROVIDED A SATISFACTORY SOLUTION FOR THE PATIENTS AND SUFFERED NO FURTHER DISPLACEMENT OF THE EXTENSOR TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663189 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention