BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7764528 · Received August 8, 2018

    Report

    Report Number
    2210968-2018-75020
    Event Type
    Injury
    Date Received
    August 8, 2018
    Report Date
    July 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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 NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND OR VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: ACTA ORTHOP TRAUMATOL TURC 2013; 47(5):307-310; DOI:10.3944/AOTT.2013.3015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : THE COMPARISON OF ETHIBOND SUTURES AND SEMITENDINOSUS AUTOGRAFT IN THE SURGICAL TREATMENT OF ACROMIOCLAVICULAR DISLOCATION AUTHOR: MOHSEN MARDANI-KIVI, AHMADREZA MIRBOLOOK, MOSTAFA SALARIYEH, KEYVAN HASHEMI-MOTLAGH, KHASHAYAR SAHEB-EKHTIARI CITATION: ACTA ORTHOP TRAUMATOL TURC 2013; 47(5):307-310; DOI:10.3944/AOTT.2013.3015. THE AIM OF THIS ANALYTICAL CROSS-SECTIONAL STUDY WAS TO EXAMINE AND COMPARE THE OUTCOMES OF ACROMIOCLAVICULAR JOINT (ACJ) RECONSTRUCTION WITH EITHER NO. 5 ETHIBOND SUTURE OR SEMITENDINOSUS AUTOGRAFT IN THE TREATMENT OF AC DISLOCATIONS. BETWEEN THE PERIODS OF SEPTEMBER 2006 AND SEPTEMBER 2009, THERE WERE 39 PATIENTS (35 MALES AND 4 FEMALES; MEAN AGE: 32.6±11.8 YEARS), WITH COMPLETE ACJ JOINT DISLOCATION (TYPE 3 TO 6). TWENTY ONE PATIENTS UNDERWENT RECONSTRUCTION USING NO. 5 ETHIBOND SUTURE (ETHICON INC., (B)(4)) (GROUP A) AND 18 PATIENTS USING SEMITENDINOSUS TENDON AUTOGRAFT (GROUP B). DURING THE PROCEDURE IN GROUP A, A TWO-FOLDED NO. 5 ETHIBOND SUTURE WAS DRIVEN BENEATH THE CORACOID AND PASSED THROUGH TWO DRILL HOLES ON THE CLAVICLE SEPARATED BY ONE CENTIMETER. THE SUTURES WERE TIED AFTER ANATOMICAL REDUCTION OF AC JOINT. IN GROUP B, FOLLOWING ANATOMICAL REDUCTION OF THE AC JOINT THE TWO TIPS OF THE TENDON WERE TIED UP ON THE CLAVICLE WITH NO. 1 VICRYL SUTURE. ONLY 11 PATIENTS IN GROUP A AND 10 PATIENTS IN GROUP B HAD A MILD PIN TRACT INFECTION WHICH WERE ALL COMPLETELY RECOVERED FOLLOWING THE REMOVAL OF THE PINS. IN CONCLUSION, TWO DIFFERENT SURGICAL TECHNIQUES PROVIDED SIMILAR RESULTS IN THE RECONSTRUCTION OF THE AC DISLOCATION IN OUR STUDY. THE DEGREE OF REDUCTION, SHOULDER FUNCTION AND PATIENT SATISFACTION WERE SIMILAR. HOWEVER, AVOIDING THE MORBIDITY OF GRAFT HARVESTING IS AN ADVANTAGE OF NO. 5 ETHIBOND SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605009 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention