BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS

    MDR report key: 3040347 · Received June 3, 2008

    Report

    Report Number
    3005180920-2008-00002
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JEA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NOT YET RECEIVED
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST CLAMP ACCIDENTALLY OPENED RESULTING IN EXCESSIVE STRESSES ON THE SECOND CLAMP THAT SUBSEQUENTLY FRACTURED. IT IS HYPOTHESIZED THAT THE FIRST CLAMP MAY HAVE OPENED DUE TO INCORRECT SETTING OF THE ADJUSTING SCREW RESULTING IN INSUFFICIENT THREAD ENGAGEMENT. SAFETY NOTIFICATION ISSUED WITH UPDATED LABELING TO ASSURE THAT BOTH CLAMPS AND STRAPS ARE USED AND TO REINFORCE PROPER ADJUSTMENT AND CONNECTION OF CLAMPS.

    Description of Event or Problem · 1

    A PRIMARY HIP SURGERY WAS BEING PERFORMED VIA AN AMIS (ANTERIOR MINIMALLY INVASIVE SURGERY) APPROACH AND USING AN AMIS MOBILE LEG POSITIONER AND UNIVERSAL TABLE CONNECTOR. DURING SURGERY TWO PROXIMAL CLAMPS OF THE UNIVERSAL TABLE FOR LEG POSITIONER DISCONNECTED FROM THE SURGICAL TABLE RESULTING IN THE PT FALLING TO THE FLOOR. THE PT SUFFERED HYPEREXTENSION OF ONE KNEE. IN ADDITION, THE ANESTHESIA TUBING WAS PULLED FROM THE PT'S THROAT. SURGERY WAS COMPLETED WITHOUT (INCIDENT AFTER REPOSITIONING THE PT ON THE SURGICAL TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIS UNIVERSAL TABLE FOR LEG POSITIONER JEA MEDACTA INTERNATIONAL, SA NA 075146

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT 062301| AMIS MOBILE LEG POSITIONER: (B)(4),