BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS LARGE BLADE (H=101 MM)

    MDR report key: 8482789 · Received April 4, 2019

    Report

    Report Number
    3005180920-2019-00225
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 3, 2019
    Report Date
    April 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040735087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 1851789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT. VISUAL INSPECTION PERFORMED BY R&D (B)(4): DURING THE ANALYSIS IT WAS NOTICED THAT THE GEOMETRY OF THE RIGHT FORK WHERE THE TOOTH IS MISSING HAD A DEFORMATION. IT IS POSSIBLE THAT THE ROOT CAUSE IS RELATED TO A BAD USAGE OF THE INSTRUMENT, DIFFERENT FROM ITS INTENDED USE.

    Description of Event or Problem · 1

    AFTER TAKING OUT THE BLADE FROM THE SCAR IT WAS NOTICED THAT ONE TOOTH WAS BROKEN. THE BROKEN PART WAS FOUND AND REMOVED FROM THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274850 AMIS LARGE BLADE (H=101 MM) SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 1851789 07630040735087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other