BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM

    MDR report key: 8639441 · Received May 24, 2019

    Report

    Report Number
    3004549189-2019-00087
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    December 9, 2015
    Report Date
    May 24, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K151004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. EVENT OCCURED IN (B)(6). NO RECOVERY OF THE DEVICE FOR EXPERTISE DESPITE REMINDERS. NO ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THESE BRAIDED BREAKAGES. CORRECTIVE ACTIONS IMPLEMENTED TO SOLVE THIS PROBLEM: REINFORCEMENT OF THE CONTROL METHOD: USE OF AN ANGLED ASSEMBLY (45°) FOR PERFORMANCE QUALIFICATION. IMPLEMENTATION OF POST-POLISHING ASPECT CONTROL: NO SCRATCHES OR UNEVENNESS WITH A BINOCULAR.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. INCIDENTS REPORTED ON 2 LOTS: "BRAID BROKE WHILE ADJUSTING PULLUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433318 PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 153155 + 153071

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other