BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 3073554 · Received April 23, 2013

    Report

    Report Number
    0009617544-2013-00153
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY. RESULTS: VISUAL INSPECTION: THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED AND THE DISTAL THREADED TIP WAS CONFIRMED TO BE BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED. DEVICE HISTORY REVIEW: NO MANUFACTURING DEVIATIONS WERE NOTED. COMPLAINT HISTORY: (B)(4). INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR I.E. OVER-ANGULATION OF THE DRAW ROD WHEN CONNECTED TO SCREW, INSUFFICIENT DEPTH OF SCREWING BETWEEN DRAW ROD AND SCREW. (B)(4). THE SURGICAL TECHNIQUE EXPLICITLY WARNS NOT TO USE THE REVISION DRIVER FOR SCREW INSERTION AND THAT THE REFLEX-HYBRID FINAL TIGHTENING SCREWDRIVER SHOULD BE USED FOR FINAL TIGHTENING. CONCLUSION: THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED AND THE DISTAL THREADED TIP WAS CONFIRMED TO BE BROKEN. THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT "WHILE THE REVISION DRIVER IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED AS THIS CAN CAUSE BENDING OR BREAKING OF THE INNER SHAFT ". THE SURGICAL TECHNIQUE ALSO STATES THAT "THE REVISION DRIVER MUST BE AXIALLY ALIGNED WITH THE SCREW TRAJECTORY AND FULLY SEATED IN THE SCREW HEAD BEFORE INSERTING OR TIGHTENING THE INNER SHAFT ". EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. THE REFLEX-HYBRID REVISION DRIVER DRAW ROD TIP IS NOW MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PATIENT. THE RATE OF FAILURE AND RELATED SEVERITIES ARE WITHIN THRESHOLDS LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REFLEX HYBRID REMOVAL. DISTAL TIP OF THE DRAW ROD BROKE UPON SCREW REMOVAL (BLUE BALL DRIVER) WAS ABLE TO USE THE FINAL DRIVER TO REMOVE REMAINING SCREWS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173439 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE 109529

    Patients

    Seq Age Sex Outcome Treatment
    1