BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7970927 · Received October 16, 2018

    Report

    Report Number
    2210968-2018-76582
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    September 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 PRODUCT (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 PRODUCT(ETHIBOND SUTURE) INVOLVED? CITATION: CHINESE JOURNAL OF ORTHOPAEDICS 2017; 37 (21): 1333-1341; DOI: 10.3760/CMA.J.ISSN.0253¿2352.2017.21.004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "A COMPARISON STUDY OF PHILOS PLATE AND MULTILOC NAIL IN TREATMENT OF PROXIMAL HUMERUS FRACTURES." AUTHORS: MING XIANG, GUOYONG YANG, YIYUAN ZOU, XIAOCHUAN HU, HANG CHEN, MINGYUE DENG, CHAOMIN GONG, YIPING LI, JINGMING DONG. CITATION: CHINESE JOURNAL OF ORTHOPAEDICS 2017; 37 (21):1333-1341; DOI: 10.3760/CMA.J.ISSN.0253¿2352.2017.21.004. THE CURRENT COMPARATIVE AIMS TO REPORT THE USE OF ANATOMICAL LOCKING PHILOS STEEL PLATE AND STRAIGHT MULTILOC INTRAMEDULLARY NAIL IN TREATING THE PROXIMAL HUMERUS FRACTURE IS STILL RARELY SEEN. FROM FEBRUARY 2013 TO DECEMBER 2015, 37 PATIENTS WITH PROXIMAL HUMERUS FRACTURE ARE INCLUDED IN THIS STUDY. THEY ARE DIVIDED INTO PHILOS STEEL PLATE GROUP AND MULTILOC INTRAMEDULLARY NAIL GROUP. THE PHILOS STEEL PLATE GROUP HAVE 18 PATIENTS, AMONG THEM 10 ARE MALES AND 8 FEMALES, AND THEIR AVERAGE AGE IS (56.3±7.4) YEARS OLD. THE MULTILOC INTRAMEDULLARY NAIL GROUP HAVE 19 PATIENTS, AMONG THEM 8 ARE MALES AND 11 ARE FEMALES; THEIR AVERAGE AGE IS (57.2±7.4) YEARS OLD. ALL THE PATIENTS TAKE SHOULDER JOINT ORTHOTOPIC POSITION DURING THE PROCEDURE AND LATERAL POSITION X-RAY FILM, AS WELL AS X-RAY FILM OF IMPROVED AXILLARY POSITION; 3-SEGMENT AND 4-SEGMENT FRACTURE WILL BE SCANNED BY CT AND UNDERGO 3D IMAGING. THE PHILOS STEEL PLATE GROUP: APPROACH VIA THE DELTOID PECTORALIS MAJOR MUSCLE AND PULL THE CEPHALIC VEIN TO THE OUTSIDE. CUT OPEN THE CLAVIPECTORAL FASCIA, FIND THE BICEPS LONG HEAD AND USE IT AS A MARK; WHEN THE FRACTURE END BECOMES VISIBLE, USE THE 5 INCH ETHIBOND THREAD TO STITCH THE ROTATOR CUFF INSERTION OF THE GREATER TUBERCLE AND LESSER TUBERCLE AND USE IT AS A PULLING THREAD SO THAT THE POSITION OF THE HUMERAL HEAD AND THE RESTORED FRACTURE BLOCK OF THE GREATER AND LESSER TUBERCLE CAN BE CONTROLLED IN THE OPERATION. THE FOCUS SHOULD BE ON THE FIXATION OF THE HUMERUS MARGIN SCREW, USE THE 2 INCH ETHIBOND THREAD OR ORTHOCORD THREAD TO SUTURE THE SUTURING HOLE FROM THE ROTATOR CUFF TENDON CONNECTED WITH THE FRACTURE BLOCK OF THE GREATER TUBERCLE AND LESSER TUBERCLE TO THE STEEL PLATE, FIX THE FRACTURE BLOCK OF THE GREATER TUBERCLE AND LESSER TUBERCLE AND INCREASE THE OVERALL STABILITY. THE MULTILOC INTRAMEDULLARY NAIL GROUP: USE THE 5 INCH ETHIBOND STITCH TO SUTURE THE ROTATOR CUFF INSERTION OF THE GREATER TUBERCLE AND "LESSEE" TUBERCLE, SO THAT THE POSITION OF THE HUMERAL HEAD AND THE REDUCED FRACTURE BLOCK OF THE GREATER TUBERCLE AND LESSER TUBERCLE. USE THE 5 INCH ETHIBOND OR ORTHOCORD STITCH TO SUTURE THE ROTATOR CUFF CONNECTED WITH THE FRACTURE BLOCK OF THE GREATER TUBERCLE AND THE LESS TUBERCLE TO THE MULTILOC NAIL HOLE TO FIX THE FRACTURE BLOCK OF THE GREATER TUBERCLE AND THE LESS TUBERCLE; WE ALSO CAN USE 2.4 MM AND 3.0 MM HERBERT NAIL TO FIX THE BIGGER TUBERCLE FRACTURE BLOCK, SO THAT THE OVERALL STABILITY CAN BE ENHANCED. AMONG ALL THE 37 PATIENTS, 9 OF THEM HAVE MILD PAIN AFTER THE OPERATION, AMONG THEM 6 PATIENTS BELONG TO THE STEEL PLATE GROUP AND 3 BELONG TO THE INTRAMEDULLARY GROUP, AND THEIR PAIN HAS BEEN RELIEVED AFTER ORALLY TAKING CELECOXIB. IN CONCLUSION, FOR THE SURGICAL TREATMENT OF THE PROXIMAL HUMERUS FRACTURE, BASED ON THE SKILLED OPERATION TECHNIQUE AND FOCUS ON POST-OPERATIVE REHABILITATION, BOTH THE LOCKING STEEL PLATE AND MULTILOC INTRAMEDULLARY NAIL CAN ACHIEVE GOOD CLINICAL EFFECT, HOWEVER FOR 2-SEGMENT FRACTURE TREATMENT THE MULTILOC INTRAMEDULLARY NAIL IS BETTER THAN THE STEEL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812321 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention