BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9382762 · Received November 27, 2019

    Report

    Report Number
    2210968-2019-90207
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 BEEN PROVIDED. CITATION: THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 41, NO. 8; DOI: 10.1177/0363546513490647 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: COMPARISON OF BONE TUNNEL AND SUTURE ANCHOR TECHNIQUES IN THE MODIFIED BROSTROM PROCEDURE FOR CHRONIC LATERAL ANKLE INSTABILITY". AUTHOR/S: CHANG-YONG HU,* MD, KEUN-BAE LEE,*+ MD, PHD, EUN-KYOO SONG,* MD, PHD, MYUNG-SUN KIM,* MD, PHD, AND KYUNG-SOON PARK,* MD, PHD. CITATION: THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 41, NO. 8; DOI: 10.1177/0363546513490647. THIS PROSPECTIVE STUDY AIMED TO COMPARE THE FUNCTIONAL AND RADIOGRAPHIC OUTCOMES OF THE MODIFIED BROSTROM PROCEDURE USING 2 DIFFERENT TECHNIQUES FOR CHRONIC LATERAL ANKLE INSTABILITY. FROM JANUARY 2005 TO SEPTEMBER 2009, A TOTAL OF 81 PATIENTS (81 ANKLES) WERE TREATED USING THE MODIFIED BROSTROM PROCEDURE. THE PATIENTS WERE DIVIDED INTO 2 GROUPS, NAMELY, A BONE TUNNEL TECHNIQUE (BT GROUP) [40 PATIENTS (40 ANKLES)] (N=32 MALES N=8 FEMALES, MEAN AGE: 34.8 YEARS, RANGE: 20-50 YEARS) AND A SUTURE ANCHOR TECHNIQUE (SA GROUP) [41 PATIENTS (41 ANKLES)] (N=33 MALES N=8 FEMALES, MEAN AGE: 33.3 YEARS, RANGE: 19-52 YEARS). IN BT GROUP, THE ATFL, CFL, AND JOINT CAPSULE WERE THEN REINSERTED INTO THE ROUGHENED SURFACE ON THE FIBULA USING NONABSORBABLE SUTURE MATERIAL (2-0 ETHIBOND) (ETHICON) WITH THE FOOT AT NEUTRAL DORSIFLEXION AND 5° OF EVERSION. IN SA GROUP, THE EXTENSOR RETINACULUM WAS REINFORCED TO THE PERIOSTEUM OF THE DISTAL FIBULA WITH INTERRUPTED 1-0 VICRYL SUTURES (ETHICON). COMPLAINTS INCLUDED ACUTE TRAUMATIC RERUPTURES AT MORE THAN 1 YEAR POSTOPERATIVELY (N=1 BT GROUP [2-0 ETHIBOND], N=1 SA GROUP [1-0 VICRYL SUTURES]) AND THESE UNDERWENT REOPERATION. ANOTHER COMPLAINT IS DECREASED IN DORSIFLEXION AND PLANTAR FLEXION (N=2 BT GROUP [2-0 ETHIBOND], N=2 SA GROUP [1-0 VICRYL SUTURES]). IN CONCLUSION, THE MODIFIED BROSTROM PROCEDURE USING THE BONE TUNNEL OR SUTURE ANCHOR TECHNIQUE WAS FOUND TO PRODUCE SIMILAR GOOD FUNCTIONAL AND RADIOGRAPHIC OUTCOMES. FURTHERMORE, BOTH TECHNIQUES APPEAR TO BE EFFECTIVE AND RELIABLE METHODS FOR THE TREATMENT OF CHRONIC LATERAL ANKLE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180226 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention