BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECOMPRESSION TUBE SNAKE ARM

    MDR report key: 3960232 · Received July 28, 2014

    Report

    Report Number
    0009617544-2014-00332
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE RETURNED INSTRUMENT WAS INSPECTED AND THE WING NUT ON THE SNAKE ARM WAS FOUND TO BE JAMMING WITHOUT FULLY TIGHTENING. THE INSTRUMENT WOULD NOT FULLY TIGHTEN BECAUSE THERE WAS SOME DEBRIS ON THE THREADING OF THE TIGHTENING MECHANISM. AFTER PROPER LUBRICATION OF THE THREADING THE FUNCTIONALITY OF THE DEVICE WAS COMPLETELY RESTORED. THERE WAS NO PERMANENT DEFORMATION OR DYSFUNCTION OF THE PRODUCT FOUND DURING INSPECTION. CONCLUSION: THE SURGICAL TECHNIQUE CLEARLY INDICATES, "NOTE: THE SNAKE ARM SHOULD BE PROPERLY RESET AND LUBRICATED BETWEEN USES." THE CAUSE OF THE REPORTED ISSUE WAS MOST LIKELY THE LACK OF LUBRICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LITE DECOMPRESSION SNAKE ARM WOULDN'T TIGHTEN WHEN SURGEON WAS ATTEMPTING TO TIGHTEN BY TURNING LEVER. CONSEQUENTLY THE SURGEON HAD TO CHANGE FROM THE PLANNED MIS PROCEDURE TO TRADITIONAL MICRODISCECTOMY

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LITE DECOMPRESSION SNAKE ARM WOULDN'T TIGHTEN WHEN SURGEON WAS ATTEMPTING TO TIGHTEN BY TURNING LEVER. CONSEQUENTLY THE SURGEON HAD TO CHANGE FROM THE PLANNED MIS PROCEDURE TO TRADITIONAL MICRODISCECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438243 DECOMPRESSION TUBE SNAKE ARM INSTRUMENT-SNAKE ARM LXH STRYKER SPINE-FRANCE 108695

    Patients

    Seq Age Sex Outcome Treatment
    1 Other