BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14519182 · Received May 26, 2022

    Report

    Report Number
    2210968-2022-04105
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    July 24, 2015
    Report Date
    May 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. COMPONENT CODE: (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ARCH ORTHOP TRAUMA SURG (2015);135:1369¿1378. DOI 10.1007/S00402-015-2295-6.

    Description of Event or Problem · 0

    TITLE: INTERFERENCE SCREW FOR FIXATION OF FDL TRANSFER IN THE TREATMENT OF ADULT ACQUIRED FLAT FOOT DEFORMITY STAGE II. THIS RETROSPECTIVE STUDY IS TO SHOW CLINICAL AND RADIOGRAPHICAL RESULTS OF PATIENTS WITH A MEDIAL DISPLACEMENT CALCANEAL OSTEOTOMY COMBINED WITH A FLEXOR DIGITORUM LONGUS TRANSFER AND RESORBABLE BIO TENODESIS SCREW FIXATION BECAUSE THEY WERE DIAGNOSED WITH ADULT ACQUIRED FLAT FOOT DEFORMITY STAGE II. 21 FEET IN 21 PATIENTS (5 MALE AND 16 FEMALE) DIAGNOSED WITH AN ADULT ACQUIRED FLAT FOOT DEFORMITY STAGE II WHO UNDERWENT OPERATIVE TREATMENT BETWEEN (B)(6) 2008 AND (B)(6) 2012 WERE INCLUDED. THE PATIENTS HAD AN AVERAGE AGE OF 51 (RANGE 18¿74) YEARS, A MEDIAN WEIGHT OF 82 (RANGE 66¿126) KILOGRAMS AND AN AVERAGE BODY-MASS-INDEX OF 28.38 KG/M2 (RANGE 24.54¿38.28) KG/M2. THEY ALL UNDERWENT FLEXOR DIGITORUM LONGUS TRANSFER (FDL) TRANSFER WITH RESORBABLE INTERFERENCE SCREW FIXATION (ARTHREX INC., NAPLES, FL, USA) AND MEDIAL DISPLACEMENT CALCANEAL OSTEOTOMY (MDCO) WITH SYNTHES CANNULATED 6.5 SYNTHES CORTICAL SCREW AS AN OPERATIVE TREATMENT. THE HARVESTED FDL TENDON IS WHIP-STITCHED WITH A 1.0 VICRYL SUTURE TO THE PROXIMAL END AND THE FDL TENDON IS FIXATED BY THE RESORBABLE BIO TENODESIS SCREW. THE MEDIAN FOLLOW-UP TIME WAS 20 (RANGE 12¿34) MONTHS. REPORTED COMPLICATIONS INCLUDE DEEP TISSUE INFECTION/WOUND HEALING PROBLEMS (N=1) REQUIRING WOUND REVISION AND THE NECESSITY TO PUT A VACUUM DRESSING TO THE WOUND TO FACILITATE WOUND HEALING. FINAL WOUND CLOSURE WAS ACHIEVED AFTER 13 MONTHS. IN CONCLUSION, THE INTERFERENCE SCREW FIXATION FOR FDL TRANSFER IS A SAFE AND PROMISING OPERATIVE TECHNIQUE, ALLOWING A SMALLER SKIN INCISION WITHOUT DISRUPTING THE NORMAL INTERCONNECTIONS AT THE KNOT OF HENRY, WHILE ACHIEVING VERY HIGH PATIENT SATISFACTION AND IMPROVING POSTOPERATIVE FUNCTION AS WELL AS RELIEVING PAIN. THIS METHOD IS TECHNICALLY EASY TO PERFORM, HAS A LOW COMPLICATION RISK AND WE, THEREFORE, RECOMMEND THIS FIXATION TECHNIQUE IN PATIENTS WITH ADULT ACQUIRED FLATFOOT DEFORMITY STAGE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715468 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention