BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SR90D M-A SCREW ADJUSTMENT TOOL

    MDR report key: 3832026 · Received May 27, 2014

    Report

    Report Number
    0009617544-2014-00236
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FUNCTIONAL EVALUATION;RESULTS: THE PRODUCT WAS RELEASED FROM MANUFACTURING OVER 11 YEARS AGO. THE INSTRUMENTS HAVE A FINITE LIFE AND ARE SUBJECT TO FATIGUE AND WEAR ASSOCIATED WITH NORMAL USE. THE MOST LIKELY CAUSE OF THE REPORTED FRACTURE IS FATIGUE OF THE INSTRUMENT OVER AN EXTENDED PRODUCT LIFETIME.CONCLUSION: THE SR90D M-A ADJUSTMENT TOOL WAS CONFIRMED TO HAVE A FRACTURE TIP, 1 OF THE 4 PRONGS FRACTURED. THE ISSUE OCCURRED WHILE THE SURGEON WAS REMOVING A SCREW DURING A REVISION SURGERY TO EXTEND THE CONSTRUCT. THE PRODUCT ISSUE CAUSED A 3 MINUTE SURGICAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING 90D REMOVE SURGERY, THE SURGEON USED THE MULTIANGLE ALIGNMENT TOOL FOR REMOVING THE SCREW. HOWEVER THE TIP OF THE MULTIANGLE ALIGNMENT TOOL BROKE. THEREFORE THE SURGEON TRIED TO REMOVE SCREW USING THE MULTIANGLE SCREW INSERTER. HOWEVER THE TIP OF THE MULTIANGLE SCREW INSERTER WAS DEFORMING. THE SURGEON USED THE BROKEN MULTIANGLE ALIGNMENT TOOL, AND REMOVED SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING 90D REMOVE SURGERY, THE SURGEON USED THE MULTIANGLE ALIGNMENT TOOL FOR REMOVING THE SCREW. HOWEVER THE TIP OF THE MULTIANGLE ALIGNMENT TOOL BROKE. THEREFORE THE SURGEON TRIED TO REMOVE SCREW USING THE MULTIANGLE SCREW INSERTER. HOWEVER THE TIP OF THE MULTIANGLE SCREW INSERTER WAS DEFORMING. THE SURGEON USED THE BROKEN MULTIANGLE ALIGNMENT TOOL, AND REMOVED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310803 SR90D M-A SCREW ADJUSTMENT TOOL INSTRUMENT LXH STRYKER SPINE-FRANCE 022731

    Patients

    Seq Age Sex Outcome Treatment
    1