BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7918731 · Received September 28, 2018

    Report

    Report Number
    2210968-2018-76148
    Event Type
    Injury
    Date Received
    September 28, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. CITATION: FOOT & ANKLE INTERNATIONAL/VOL. 29, NO. 8/AUGUST 2008 DOI: 10.3113/FAI.2008.0803. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: OUTCOME OF ACHILLES TENDON RUPTURES TREATED BY A LIMITED OPEN TECHNIQUE" AUTHOR(S): HONG GEUN JUNG, MD, PHD; KEUN BAE LEE, MD, PHD; SANG GWON CHO, MD; TAEK RIM YOON, MD, PHD CITATION: FOOT & ANKLE INTERNATIONAL/VOL. 29, NO. 8/AUGUST 2008 DOI: 10.3113/FAI.2008.0803. THE PURPOSE OF THE PRESENT STUDY WAS TO EVALUATE THE OUTCOMES OF THIS LIMITED OPEN TECHNIQUE FOR THE TREATMENT OF ACHILLES TENDON RUPTURES AND TO COMPARE THE RESULTS OBTAINED WITH THOSE OF PREVIOUSLY REPORTED STUDIES. FROM JUNE 2003 TO MAY 2006, 30 PATIENTS (20 MEN AND 10 WOMEN) WITH ACHILLES TENDON RUPTURES DUE TO SPORTS-RELATED INJURIES (N=20), FALL (N=8) AND LACERATION (N=2). IN THE PROCEDURE THREE NO. 2 ETHIBOND SUTURES WERE USED AND TIGHTENED IN PAIRS SUCH THAT BOTH ENDS OF THE RUPTURED STUMPS MET CORRECTLY UNDER PROPER TENSION COMPARED TO THE OPPOSITE LEG. ADDITIONAL 1.0 VICRYL SUTURES WERE THEN PLACED TO REINFORCE THE RECONSTRUCTION SITE DEPENDING ON THE CHARACTERISTICS OF THE RUPTURED TENDON. POSTOPERATIVELY, A DEEP INFECTION WAS PRESENT IN A (B)(6) FEMALE PATIENT POD 3 WEEKS WHICH WAS TREATED BY THREE OPERATIVE INTERVENTIONS, WITH REPEATED DEBRIDEMENT AND HEALING WAS ACHIEVED AT 3 MONTHS. A MINOR COMPLICATION OF SURAL NERVE INJURY WAS REPORTED BY A (B)(6) FEMALE PATIENT WHICH RESOLVED SPONTANEOUSLY AT 8 WEEKS POSTOPERATIVELY. THE TWO CASES OF RE-RUPTURE WAS RELATED TO ACCIDENTAL FULL WEIGHT-BEARING DUE TO FALL FROM A HEIGHT AT POSTOPERATIVE 10 WEEKS, AND TO IMMEDIATE FULL WEIGHT-BEARING WITHOUT AN AFO DURING THE EARLY POSTOPERATIVE PERIOD. THE DESCRIBED LIMITED OPEN REPAIR TECHNIQUE FOR ACHILLES TENDON RUPTURES PROVIDED EXCELLENT COSMETIC RESULTS, SATISFACTORY FUNCTIONAL RESULTS, AND A HIGH LEVEL OF PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760101 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ETHIBOND SUTURE