BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE

    MDR report key: 9759524 · Received February 26, 2020

    Report

    Report Number
    0002936485-2020-00088
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    February 5, 2020
    Report Date
    April 14, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    UDI-DI
    37613327464833
    PMA / PMN Number
    K181083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE ALLEGED FAILURE: ANCHOR REMAINED LOOSE IN THE PATIENT PROBABLE ROOT CAUSE: THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REO"DESIGN - INADEQUATE RAW MATERIAL SELECTION FOR SCREW - DESIGN GEOMETRY TOO SENSITIVE TO WITHSTAND CLINICAL IMPACTION LOADS - SCREW/DRIVER INTERFACE NOT DESIGNED TO MAINTAIN PROPER ASSEMBLY PROCESS - SCREW OR DRIVER NOT MANUFACTURED TO SPECIFICATION - INCORRECT MATERIAL USED DURING MANUFACTURING - SCREW AND DRIVER NOT ASSEMBLED TO SPECIFICATION APPLICATION - EXCESSIVE FORCE OR LEVERAGING OF THE SCREW AGAINST THE BONE - INADEQUATE ASSESSMENT OF BONE QUALITY, PILOT HOLE NOT PREPARED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR REMAINS LOOSE IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR REMAINS LOOSE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219175 OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE 19324AG2 37613327464833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other