BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULIF PL TUBING SET

    MDR report key: 4211176 · Received October 29, 2014

    Report

    Report Number
    3004024955-2014-00020
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    PMA / PMN Number
    K141217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: INSTRUCTIONS FOR ATTACHING AND DETACHING THE TUBING SET TO THE INSERTION HANDLE ARE DETAILED IN THE SURGICAL TECHNIQUE. THE TUBING SET SHOULD BE INSERTED BY APPLYING DOWNWARD PRESSURE AND THEN ROTATED CLOCKWISE. THE MATERIALS ANALYSIS RESULTS INDICATED THAT THE WELD FRACTURED AS A RESULT OF AN APPLIED CANTILEVER LOAD. THE SIDECAR SUB-COMPONENT OF THE TUBING SET IS NOT INTENDED TO EXPERIENCE CANTILEVER LOADING DURING ATTACHMENT OR PRESSURIZATION OF THE DEVICE. A CANTILEVER LOAD WOULD LIKELY BE APPLIED DURING ATTACHED OR DETACHMENT FROM THE TUBING SET. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS A USER APPLIED CANTILEVER LOAD.

    Description of Event or Problem · 1

    SALES REP. REPORTED THAT OUR ACCULIF PL LOANER INSERTER WAS SPRAYING WATER FROM THE CONNECTING TUBE. THEY RETURNED IT AFTER HIS CASE TO LOANERS.

    Description of Event or Problem · 1

    SALES REP. REPORTED THAT OUR ACCULIF PL LOANER INSERTER WAS SPRAYING WATER FROM THE CONNECTING TUBE. THEY RETURNED IT AFTER HIS CASE TO LOANERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691934 ACCULIF PL TUBING SET INSTRUMENT MAX STRYKER SPINE-FRANCE 06241407

    Patients

    Seq Age Sex Outcome Treatment
    1