BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8206738 · Received December 31, 2018

    Report

    Report Number
    2210968-2018-78094
    Event Type
    Injury
    Date Received
    December 31, 2018
    Report Date
    December 13, 2018
    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 NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) 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 PRODUCTS (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: INTERNATIONAL ORTHOPAEDICS (SICOT). 2016; 40: 569¿577. DOI: 10.1007/S00264-015-2950-0.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : CLINICAL AND RADIOLOGICAL OUTCOMES OF UNSTABLE PROXIMAL HUMERAL FRACTURES TREATED WITH A LOCKING PLATE AND FIBULAR STRUT ALLOGRAFT". AUTHOR: KARNAV PANCHAL1 & JAE-JUNG JEONG1 & SANG-EUN PARK1 & WEON-YOO KIM1 & HYUNG-KI MIN1 & JU-YEONG KIM1 & JONG-HUN JI1. CITATION: INTERNATIONAL ORTHOPAEDICS (SICOT). 2016; 40: 569¿577. DOI: 10.1007/S00264-015-2950-0. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF UNSTABLE PROXIMAL HUMERAL FRACTURES (PHFS) TREATED WITH A LOCKING PLATE AND FIBULAR STRUT ALLOGRAFT. THIS STUDY INCLUDED 36 PATIENTS (7 MEN AND 29 WOMEN; AGE RANGE: 22 TO 94 YEARS OLD) WITH UNSTABLE PHFS WITH MEDIAL COLUMN DISRUPTION. ALL PATIENTS WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION USING A LOCKING PLATE AND FIBULAR STRUT ALLOGRAFT. DURING THE SURGICAL PROCEDURE, THE LONG HEAD OF THE BICEPS WAS ISOLATED AND WAS DETACHED PROXIMALLY. THE GREATER TUBEROSITY (GT) FRACTURE FRAGMENT WAS RETRACTED BY PLACING ETHIBOND 2-0 SUTURES (ETHICON) THROUGH THE BONE-TENDON JUNCTION OF THE ROTATOR CUFF MUSCLES. THE INSERTED FIBULAR GRAFT MAINTAINED A GOOD ALIGNMENT OF THE FRACTURE, AND THE LOCKING PLATE WAS EASILY APPLIED TO THE FRACTURE SITE. ETHIBOND 2-0 SUTURES (ETHICON) WERE USED TO ATTACH THE HUMERAL HEAD FRACTURE FRAGMENT TO THE LESSER TUBEROSITY AND ALSO THE LESSER TUBEROSITY TO THE GREATER TUBEROSITY. CHIP BONE ALLOGRAFT COULD BE USED IN THE BONE DEFECT SITE. USING ETHIBOND 2-0 SUTURES (ETHICON), METICULOUS REPAIR OF THE ROTATOR CUFF TO THE PLATE WAS CARRIED OUT. REPORTED COMPLICATIONS INCLUDED VARUS COLLAPSE (N-2) WHICH REQUIRED FURTHER SURGICAL INTERVENTION, SUCH AS REFIXATION OR ARTHROPLASTY, BUT THEY BOTH REFUSED TO UNDERGO ANY TREATMENT, AVASCULAR NECROSIS OF THE HUMERAL HEAD (N-2) WHICH REQUIRED FURTHER SURGICAL INTERVENTION, SUCH AS REFIXATION OR ARTHROPLASTY, BUT THEY BOTH REFUSED TO UNDERGO ANY TREATMENT, ADHESIVE CAPSULITIS (N-2) WHICH REQUIRED PLATE REMOVAL AND SHOWED SATISFACTORY FINAL OUTCOME. THE STUDY DEMONSTRATES THAT UNSTABLE, COMPLEX PHFS WITH MEDIAL COMMINUTION CAN BE RELIABLY TREATED WITH JOINT PRESERVING TECHNIQUES USING FIBULAR ALLOGRAFTS AND LOCKING PLATES TO RESTORE THE INTEGRITY OF THE MEDIAL COLUMN, SUPPORT THE HUMERAL HEAD, AND MAINTAIN REDUCTION UNTIL THE FRACTURE CAN HEAL. A SECOND COLUMN OF SUPPORT IS EASILY ESTABLISHED: THE STABILITY OF THE RECONSTRUCTION HAS IMPROVED, AND REDUCTION IS MAINTAINED. THIS MINIMIZES THE MOST FREQUENT COMPLICATIONS REPORTED WITH PROXIMAL HUMERAL LOCKING PLATES AND ALLOWS FOR EARLY AND AGGRESSIVE REHABILITATION WITH GREATER PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045216 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention