BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 7426273 · Received April 12, 2018

    Report

    Report Number
    2210968-2018-72108
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE. THE DEVICE WAS NOT RETURNED, THEREFORE AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. THE LOT/BATCH WAS NOT PROVIDED, THEREFORE THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: AUGMENTED COMPARED WITH NON-AUGMENTED SURGICAL REPAIR OF A FRESH TOTAL ACHILLES TENDON RUPTURE AUTHORS: ARI PAJALA, MD, JARMO KANGAS, MD, PERTTI SIIRA, PHT, PASI OHTONEN, MSC, AND JUHANA LEPPILAHTI, MD, PHD CITATION: J BONE JOINT SURG AM. 2009; 91: 1092 100. DOI: 10.2106/JBJS.G.01089 AUGMENTED AND NON-AUGMENTED TECHNIQUES HAVE BEEN USED FOR THE OPERATIVE REPAIR OF A FRESH COMPLETE ACHILLES TENDON RUPTURE. AUGMENTED TECHNIQUES HAVE BEEN FAVORED FOR THEIR STRONGER PULL-OUT STRENGTHS BUT HAVE BEEN AVOIDED BECAUSE OF THE RISK OF WOUND COMPLICATIONS. THE AUTHORS HYPOTHESIZED THAT AUGMENTATION WITH A DOWN-TURNED GASTROCNEMIUS FASCIA FLAP WOULD NOT PROVIDE BETTER RESULTS THAN WOULD END-TO-END SUTURE REPAIR WITH USE OF THE KRACKOW LOCKING LOOP SURGICAL TECHNIQUE. A TOTAL OF 60 PATIENTS WITH AN ACUTE ACHILLES TENDON RUPTURE WERE RANDOMIZED TO RECEIVE END-TO-END SUTURE REPAIR WITH USE OF THE KRACKOW LOCKING LOOP TECHNIQUE EITHER WITHOUT AUGMENTATION (SIMPLE REPAIR GROUP; 32 PATIENTS) OR REPAIR BY MEANS OF AUGMENTATION WITH A DOWN-TURNED GASTROCNEMIUS FASCIA FLAP (AUGMENTED REPAIR GROUP; 28 PATIENTS). DURING THE SURGICAL PROCEDURE IN BOTH GROUPS, IRREGULAR TENDON ENDS WERE CLEANED AND REPAIRED WITH THE KRACKOW TECHNIQUE AS DESCRIBED WITH USE OF TWO SEPARATE PDS 0 SUTURES AND VICRYL 2-0 SUTURES. IN THE SIMPLE REPAIR GROUP, NO AUGMENTATION WAS USED WHEREAS IN THE AUGMENTED REPAIR GROUP, A 10-MM-WIDE CENTRAL GASTROCNEMIUS APONEUROSIS FLAP WAS TURNED DOWN OVER THE RUPTURE REPAIR AND WAS SUTURED TO THE DISTAL PART OF THE ACHILLES TENDON WITH VICRYL 2-0 SUTURES. IN ALL CASES AFTER REPAIR, THE FASCIA WAS CAREFULLY RE-SUTURED WITH VICRYL, AND THE SKIN WAS CLOSED WITH ETHILON SUTURES. IT WAS REPORTED THAT A (B)(6) MAN IN THE AUGMENTED REPAIR GROUP HAD A DEEP INFECTION. HE HAD DEVELOPMENT OF CLEAR DRAINAGE FROM THE INCISION AT THREE WEEKS. HE IMMEDIATELY UNDERWENT WOUND DEBRIDEMENT, AND THE ´ WOUND WAS LEFT OPEN. CULTURES OF SPECIMENS FROM THE WOUND WERE NEGATIVE. AFTER THE PATIENT HAD RECEIVED SEVEN DAYS OF TREATMENT WITH INTRAVENOUS ANTIBIOTICS, WE WERE ABLE TO CLOSE THE WOUND WITH A TWO-TAILED CUTANEOUS TURNOVER FLAP, AND IT HEALED WITHOUT FURTHER EVIDENCE OF INFECTION. THE PATIENT WAS ABLE TO WALK NORMALLY AT THE TIME OF THE ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269096 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention