BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12491068 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08620
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 24, 2021
    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

    PRODUCT COMPLAINT # (B)(4). HEALTH EFFECT: CLINICAL CODES: (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. 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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (RE-RUPTURE (N=?); UNRECOVERED NERVE INJURY (N = ?); HETEROTOPIC OSSIFICATION (N=?); NEURAPRAXIA (N=?); SUPERFICIAL INFECTION (N=?)) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE) USED FOR CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE A COMPLETE PATIENT DEMOGRAPHICS FOR PATIENTS WITH POST-OP COMPLICATIONS (RE-RUPTURE (N=?); UNRECOVERED NERVE INJURY (N = ?); HETEROTOPIC OSSIFICATION (N=?); NEURAPRAXIA (N=?); SUPERFICIAL INFECTION (N=?))? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: THE BONE & JOINT JOURNAL (2021);103-B(7):1284¿1291. DOI:10.1302/0301-620X.103B7. BJJ-2020-2246.R1. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: ACUTE DISTAL BICEPS TENDON REPAIR USING CORTICAL BUTTON FIXATION RESULTS IN EXCELLENT SHORT, AND LONG-TERM OUTCOMES: A SINGLE-CENTRE EXPERIENCE OF 102 PATIENTS THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE PATIENT-REPORTED OUTCOME AND HEALTH-RELATED QUALITY OF LIFE (HRQOL) FOLLOWING ACUTE DISTAL BICEPS TENDON REPAIR USING CORTICAL BUTTON FIXATION IN A LARGE SINGLE-CENTRE CONSECUTIVE SERIES OF PATIENTS. BETWEEN OCTOBER 2010 AND JULY 2018, A TOTAL OF 102 PATIENTS [101 MALE AND 1 FEMALE; MEAN AGE OF 43 YEARS (19 TO 67)] WITH A DISTAL BICEPS TENDON RUPTURE UNDERWENT DISTAL BICEPS TENDON REPAIR USING CORTICAL BUTTON FIXATION. SURGERY WAS PERFORMED USING A WHIPSTITCH OF EITHER TWO NO. 5 ETHIBOND (ETHICON, USA) OR TWO ORTHOCORD (JOHNSON & JOHNSON, USA) SUTURES, THEN SECURED USING A 4 MM X 12 MM CORTICAL BUTTON FROM A COMPETITOR. THE MEAN SHORT-TERM CLINICAL FOLLOW-UP WAS 4.1 MONTHS (2.0 TO 55.5). REPORTED COMPLICATIONS INCLUDED RE-RUPTURE (N=?) WHICH REQUIRED FURTHER SURGERY IN 2 PATIENTS; UNRECOVERED NERVE INJURY (N = ?); HETEROTOPIC OSSIFICATION (N=?) WHICH WAS SIGNIFICANTLY LIMITING ROTATION OF THE FOREARM FOUR MONTHS FOLLOWING REPAIR AND REQUIRED FURTHER SURGERY FOR EXCISION; NEURAPRAXIA (N=?); SUPERFICIAL INFECTION (N=?). IN CONCLUSION, ACUTE DISTAL BICEPS TENDON REPAIR USING CORTICAL BUTTON FIXATION WAS FOUND TO RESULT IN EXCELLENT PATIENT-REPORTED OUTCOMES AND HEALTH-RELATED QUALITY OF LIFE. ALTHOUGH RARE, UNRECOVERED NERVE INJURY ADVERSELY AFFECTS OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386095 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention