BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITIONER, SHOULDER EXPOSURE T-MAXII

    MDR report key: 4103282 · Received September 19, 2014

    Report

    Report Number
    1643264-2014-00023
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    May 22, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION DISCOVERED THE SLIDING LEG HAD BEEN WARPED AND BENT. DURING FUNCTIONAL EVALUATION THE UNIT PASSED TESTING AND NO SLIPPAGE OCCURRED. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    BEFORE AN ACL RECONSTRUCTION WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, IT WAS REPORTED THAT THE T-MAX ASSEMBLY SLIPPED OFF BED RAILS CAUSING THE PATIENT TO FALL TO THE FLOOR. WHILE PLACING THE BOLSTER PAD UNDER THE PATIENT THE T-MAX AND PATIENT BEGAN TO SLIP OFF OF THE BED. THE PATIENT LANDED ON THE FLOOR AS THE STAFF WAS NOT ABLE TO SUPPORT THE PATIENT¿S WEIGHT. THE PATIENT UNDERWENT AN X-RAY OF THE NECK AREA WHILE STILL ANESTHETIZED. NO INJURY WAS FOUND UPON REVIEWING THE FILM. THE PATIENT WAS AWAKENED AND SENT HOME. THE PROCEDURE WAS RE-SCHEDULED FOR ONE WEEK LATER. IT WAS COMPLETED AND PATIENT IS RECOVERING AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582412 POSITIONER, SHOULDER EXPOSURE T-MAXII ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC. 7210551

    Patients

    Seq Age Sex Outcome Treatment
    1