BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS TABLE

    MDR report key: 5031082 · Received August 26, 2015

    Report

    Report Number
    5031082
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    February 10, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MEDACTA USA
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RNFP CONNECTED THE MEDACTA HIP BED ATTACHMENT ON THE OPERATING ROOM BED BECAUSE THE REP HAD NOT ARRIVED. THE REP ARRIVED, ADJUSTED A FEW A STRAPS THEN VERIFIED CORRECT PLACEMENT OF THE ATTACHMENT. THE PATIENT WAS TRANSFERRED FROM THE STRETCHER TO THE OPERATING ROOM BED. IT WAS NOTED THE ATTACHMENT WAS APPROXIMATELY 3 INCHES FURTHER SOUTH ON THE BED THAN IT SHOULD BE BECAUSE THE CASSETTES ON THE BED DIDN'T ALLOW FOR IT TO BE SLID UP TO THE CORRECT POSITION. THE PATIENT WAS PREPPED, DRAPED AND SURGICAL PROCEDURE STARTED. DURING THE PROCEDURE THERE WERE A FEW POPPING NOISES THAT ALERTED THE STAFF THAT SOMETHING WAS NOT RIGHT. SCREWS THAT HOLD THE POSITIONER TO THE BED CLAMPS WERE BREAKING LOOSE. ORTHO TEAM MANAGER WAS NOTIFIED. THE SURGERY PROCEEDED. AFTER APPLYING DOWNWARD PRESSURE TO THE FEMUR, MORE POPPING NOISES WERE HEARD. THE POSITION WAS RE-EVALUATED AND DEEMED UNSAFE FOR THE PATIENT. A RING STAND AND STANDING STOOL WERE PLACED UNDER THE FOOT PORTION OF THE ATTACHMENT. PEG BOARD ATTACHMENT HOLDERS WERE PLACED ON THE HEAD PORTION OF THE POSITIONER AND THIS SECURED THE POSITIONER DOWN TO THE BED. THE PROCEDURE WAS COMPLETED. NO HARM TO PATIENT. POST-OP INSPECTION REVEALED THAT THE ATTACHMENT INTEGRITY WAS COMPLETELY COMPROMISED. THE BRACKETS ATTACHING THE POSITIONER TO THE BED CLAMPS WERE BROKE AND ALL OF THE SCREWS THAT HELD THE ATTACHMENT TO THE PLASTIC BACKING WERE PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563765 AMIS TABLE TABLE, OPERATING-ROOM, MECHANICAL FWX MEDACTA USA

    Patients

    Seq Age Sex Outcome Treatment
    1