BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBUTTON

    MDR report key: 9746772 · Received February 24, 2020

    Report

    Report Number
    1219602-2020-00392
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Report Date
    March 27, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION IS NOT POSSIBLE, AS THE UNKNOWN ENDOBUTTON DEVICE WILL NOT BE RETURNED. THE PART AND LOT NUMBER HAVE NOT BEEN PROVIDED MAKING AN EXAMINATION OF THE MANUFACTURING RECORDS PROHIBITIVE, HOWEVER A REVIEW OF THE RISK MANAGEMENT, LABELING AND INSTRUCTIONS FOR USE DOCUMENTATION WAS REVIEWED FOR THIS DEVICE FAMILY AND FOUND TO CONTAIN STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE COMPLAINT RECORDS WAS ALSO PERFORMED FOR THIS DEVICE FAMILY, WHICH CONFIRMED ADDITIONAL COMPLAINTS HAVE BEEN REPORTED WITHIN THE SCOPE OF THE REPORTED STUDY. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THIS INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE LIMITED CLINICAL DETAILS PROVIDED. IF ADDITIONAL CLINICAL DETAILS BECOME AVAILABLE IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED. THIS COMPLAINT WAS REPORTED FROM THE LITERATURE REVIEW. THE RESULTS OF THE STUDY SHOWED GROUP 2 (ECL-BTB) HAD 11 MINUTES SHORTER OPERATION TIME DUE TO THE ASSISTANT SURGEON BEING ABLE TO START FASHIONING THE HYBRID GRAFT IMMEDIATELY AFTER TENDON HARVEST AND COMPLETE IT BEFORE THE SURGEON MEASURES THE FEMORAL TUNNEL LENGTH. IN THE STUDYING IT WAS REPORTED THAT AFTER TWO YEARS OF SURGERY WITH AN ENDOBUTTON-ECL, THE PATIENT HAD MODERATE KNEE PAIN. THE EVENT WAS TREATED WITH AN ARTHROSCOPIC EXAMINATION, PARTIAL MENISCECTOMY, AND MENISCAL REPAIR. IT IS UNKNOWN THE OUTCOME OF THE PATIENT. AFTER THREE REQUESTS NO INDIVIDUAL CLINICAL INFORMATION HAS BEEN PROVIDED FOR INCLUSION IN THIS MEDICAL INVESTIGATION. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. SHOULD INFORMATION BECOME AVAILABLE THIS COMPLAINT CAN BE RE-ASSESSED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO YEARS OF SURGERY WITH AN ENDOBUTTON-ECL, THE PATIENT HAD MODERATE KNEE PAIN. THE EVENT WAS TREATED WITH AN ARTHROSCOPIC EXAMINATION, PARTIAL MENISCECTOMY, AND MENISCAL REPAIR. IT IS UNKNOWN THE OUTCOME OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208186 ENDOBUTTON FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other