BEUDAMED
    FDA Adverse Event Summary report: N

    BACKHAUS

    MDR report key: 5107889 · Received September 22, 2015

    Report

    Report Number
    3007208013-2015-00023
    Date Received
    September 22, 2015
    Date of Event
    July 28, 2015
    Report Date
    September 21, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HXD
    UDI-DI
    00887482008362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYMMETRY SURGICAL PROVIDED THE CUSTOMER WITH A SUMMARY IN RESPONSE TO THE REPORTED ISSUE WITH THE BACKHAUS TOWEL CLAMP. THE QUALITY ASSURANCE INVESTIGATION IS COMPLETE WITH THE FOLLOWING RESULTS: THE EVALUATION OF THIS INSTRUMENT FOUND THAT THE DEVICE WAS USED TO CLAMP DOWN ON THE RADIUS WHICH IS BEYOND THE INTENDED USE OF THE DEVICE.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC PROCEDURE A TOWEL CLAMP WAS PUT ON THE RADIUS TO CLAMP DOWN AND PULL UP ON THE RADIUS WHILE TRYING TO GET THE TRIAL HEAD ON THE RADIAL TRIAL INSERT. IT WAS AT SOME POINT DURING THIS PART OF THE PROCEDURE THAT THE TOWEL CLAMP FRACTURED ON THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625573 BACKHAUS TOWEL CLAMP HXD SYMMETRY SURGICAL INC. 32-5005 00887482008362

    Patients

    Seq Age Sex Outcome Treatment
    1