BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE

    MDR report key: 7400498 · Received April 5, 2018

    Report

    Report Number
    2210968-2018-71934
    Event Type
    Injury
    Date Received
    April 5, 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, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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. IN THE SIMPLE REPAIR GROUP, REPORTED COMPLICATIONS INCLUDED RE-RUPTURE (N-3) AND SUPERFICIAL WOUND INFECTION (N-4) WHICH REQUIRED ORAL ANTIBIOTICS. IN THE AUGMENTED REPAIR GROUP, REPORTED COMPLICATIONS INCLUDED RE-RUPTURE (N-3), SUPERFICIAL WOUND INFECTION (N-1) WHICH REQUIRED ORAL ANTIBIOTICS, DEEP VEIN THROMBOSIS (N-1) WHICH REQUIRED WARFARIN TREATMENT FOR 6 MONTHS. IN CONCLUSION, THE AUGMENTED REPAIR IN CASES OF FRESH COMPLETE ACHILLES TENDON RUPTURE DOES NOT HAVE ANY ADVANTAGE OVER SIMPLE END-TO-END REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244187 PDS II POLYDIOXANONE SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention