BEUDAMED
    FDA Adverse Event Summary report: N

    HOEN

    MDR report key: 5147864 · Received October 8, 2015

    Report

    Report Number
    3007208013-2015-00026
    Date Received
    October 8, 2015
    Date of Event
    August 13, 2015
    Report Date
    October 7, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYMMETRY DID NOT RECEIVE THE BROKEN DEVICE BACK FROM THE HOSPITAL. DEVICE FAILURE WAS DETERMINED TO BE MISUSE OF THE PRODUCT. INSTRUMENT SPECIALIST ON SITE INDICATED: DEVICE IS INTENDED TO SEPARATE THE DURA MATER THAT COATS THE BRAIN AND THE SPINAL CORD, DEVICE SHOULD NOT BE STRUCK.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR DISCECTOMY THE TIP OF THE HOEN DURAL SEPARATOR BROKE OFF INSIDE THE PATIENT WHEN STRUCK WITH A MALLET BY THE SURGEON. A C-ARM X-RAY WAS BROUGHT IN TO LOCATE THE BROKEN TIP THAT WAS IN THE PATIENT. THE BROKEN PIECE WAS RECOVERED WITHOUT HARM TO THE PATIENT. THE DEVICE WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670292 HOEN DURAL SEPARATOR GAF SYMMETRY SURGICAL INC. 65-1102

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR