BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITPC 30 8X25MM CANNULA 1,2MM

    MDR report key: 8502629 · Received April 11, 2019

    Report

    Report Number
    3004549189-2019-00024
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    April 11, 2016
    Report Date
    March 22, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. NO POSSIBLE RECOVERY OF THE SCREW: THE ORIGIN OF THE FRACTURE REMAINS UNIDENTIFIABLE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "DURING AN ACL PROCEDURE, WHILE THE SURGEON TRIED TO IMPLANT THE SCREW INTO THE FEMORAL TUNNEL, THE SCREW FRACTURED. FRACTURED PIECES REMAIN IN PATIENT. THE SCREW BROKE WHEN IT WAS PARTIALLY IMPLANTED, SO IT WAS LEFT IN THE PATIENT AND THE SURGERY WAS TERMINATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298283 COMPOSITPC 30 8X25MM CANNULA 1,2MM INTERFERENCE SCREW MAI S.B.M. SAS 152633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other