BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-MAX II SHOULDER EXPOSURE POSITIONER

    MDR report key: 5292419 · Received December 12, 2015

    Report

    Report Number
    3003604053-2015-00117
    Event Type
    Injury
    Date Received
    December 12, 2015
    Date of Event
    October 12, 2015
    Report Date
    November 12, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - THE SUBJECT DEVICE, A T-MAX EXPOSURE SHOULDER POSITIONER, PART NUMBER 7210551 WITH SERIAL NUMBER (B)(4), WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION AND THUS A VISUAL AND FUNCTIONAL INVESTIGATION COULD NOT BE PERFORMED NOR COULD A ROOT CAUSE BE DETERMINED WITH CONFIDENCE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THE DEVICE WAS RELEASED TO DISTRIBUTION ON OR ABOUT DECEMBER 31, 2008 AND MET SPECIFICATION UPON RELEASE. THIS DEVICE WAS IN SERVICE FOR APPROXIMATELY SEVEN YEARS PRIOR TO THE REPORTED EVENT AND IS SUBJECT WITH WEAR AND TEAR THROUGH USE OVER TIME. ALTHOUGH A ROOT CAUSE ASSOCIATED WITH THIS EVENT CANNOT BE DETERMINED WITH CONFIDENCE, FACTORS WHICH COULD HAVE CONTRIBUTED INCLUDE IMPROPER SETUP AND WEAR OF THE RETAINING MECHANISMS FOR USE OVER TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. IN THE EVENT THE SAMPLE IS RETURNED FOR EVALUATION THE COMPLAINT WILL BE REOPENED FOR ADDITIONAL INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE T-MAX EXPOSURE SHOULDER POSITIONER BECAME LOOSE FROM THE BED CAUSING THE PATIENT TO FALL ON THE FLOOR. NO PATIENT INJURY NOTED. THERE IS NO REPORT OF HOW LONG OF A SURGICAL DELAY, IF ANY, RESULTED. THERE IS NO REPORT OF WHAT MIGHT HAVE BEEN USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821296 T-MAX II SHOULDER EXPOSURE POSITIONER ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention