BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7778089 · Received August 13, 2018

    Report

    Report Number
    2210968-2018-75120
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 SUTURE) USED IN THIS PROCEDURE? CITATION: ARCH ORTHOP TRAUMA SURG (2013) 133:1361¿1366; DOI 10.1007/S00402-013-1819-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : HIGH COMPLICATION RATE FOLLOWING DISTAL BICEPS REFIXATION WITH CORTICAL BUTTON AUTHOR: MARC BANERJEE ¿ SVEN SHAFIZADEH ¿ BERTIL BOUILLON ¿ THORSTEN TJARDES ¿ ARASCH WAFAISADE ¿ MAURICE BALKE CITATION: ARCH ORTHOP TRAUMA SURG (2013) 133:1361¿1366; DOI 10.1007/S00402-013-1819-1. THE AIM OF THIS RETROSPECTIVE ANALYSIS WAS TO ASSESS THE FUNCTIONAL RESULTS AND ANY COMPLICATIONS RELATED TO THE TRANSOSSEOUS BUTTON FIXATION TECHNIQUE. BETWEEN 2004 AND 2011, 32 MALE PATIENTS WITH DISTAL BICEPS TENDON RUPTURE UNDERWENT OPERATIVE TREATMENT IN CORTICAL BUTTON TECHNIQUE. IN THE PROCEDURE, THE DISTAL END OF THE TORN BICEPS TENDON WAS WHIP-STITCHED USING A RUNNING BASEBALL STITCH WITH TWO NO. 3 ETHIBOND SUTURES WHICH WERE TIED ON A CORTICAL BUTTON WITH A DISTANCE OF ABOUT 2 MM AWAY FROM THE END OF THE TENDON. AT AN AVERAGE FOLLOW-UP OF 36.1 MONTHS, COMPLICATIONS INCLUDED HETEROTROPHIC OSSIFICATION (N=3) IN WHICH IN ONE NEEDED TO BE PARTIALLY REMOVED DUE TO SEVERE OSSIFICATION, RE-RUPTURE OF THE DISTAL BICEPS TENDON (N=1) IN WHICH THIS PATIENT UNDERWENT TENDON REPAIR IN CORTICAL BUTTON TECHNIQUE, WOUND HEALING DISORDER (N=2) OF WHICH ONE HAD TO BE REVISED, HYPERTROPHIC SCAR (N=1), AND ENDOBUTTON DISLOCATION (N=1) WHICH WAS REVISED 10 DAYS AFTER SURGERY. THE MOST COMMON COMPLICATION IN THE PRESENT STUDY WAS NEURAPRAXIA OF THE POSTERIOR INTEROSSEOUS NERVE. IT WAS OUR INTENTION TO HAVE THE GREATEST POSSIBLE INTRAOSSEOUS COURSE OF THE TENDON BY DRILLING OBLIQUE WITH THE DRILL DIRECTED DISTALLY; HOWEVER, THIS MAY HAVE CAUSED THE NERVE DAMAGE AS THE NERVE CAN BE TRAPPED BETWEEN THE BUTTON AND THE RADIUS. THE COMPLICATION RATE OF DISTAL BICEPS TENDON FIXATION USING TRANSOSSEOUS SUTURES STABILISED WITH BUTTONS WAS AS HIGH AS 33 %. IN THE AUTHORS¿ OPINION, IMPROVING SURGICAL SKILLS, INCLUDING KNOWLEDGE OF ANATOMY, THE HANDLING OF RETRACTORS, THE DRILLING DIRECTION AND KNOWLEDGE OF SPECIFIC PITFALLS RELATED TO THE TYPE OF FIXATION ARE MANDATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618533 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention