BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE

    MDR report key: 7426574 · Received April 12, 2018

    Report

    Report Number
    2210968-2018-72114
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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. (B)(4).

    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/(B)(4). 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)-OLD MAN IN THE AUGMENTED REPAIR GROUP HAD A DEEP INFECTION. HE HAD DRAINAGE FROM THE LOWER EDGE OF THE WOUND. AT SIX WEEKS, THE WOUND WAS DEBRIDED AND WAS LEFT OPEN. THE BACTERIAL CULTURES ´ WERE (B)(6) FOR BOTH (B)(6). THE ACHILLES TENDON HAD ALREADY PARTIALLY HEALED. AFTER TREATMENT WITH REPEATED DEBRIDEMENTS AND ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS, THE WOUND WAS CLOSED WITH A TWO-TAILED CUTANEOUS TURNOVER FLAP, WHICH SHOWED EPIDERMAL NECROSIS AT FIRST BUT EVENTUALLY HEALED WELL. THE PATIENT WAS WALKING WELL AT THE TIME OF THE ONE-YEAR FOLLOW-UP AND WAS SATISFIED WITH THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267742 PDS II POLYDIOXANONE SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention