BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2190938 · Received July 19, 2011

    Report

    Report Number
    9617544-2011-00249
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, MFG RECORD REVIEW, RISK REVIEW, PHOTOGRAPHS. RESULT: VISUAL INSPECTION CONFIRMS TIPS OF BOTH INSTRUMENTS ARE BROKEN. BROKEN FRAGMENTS NOT RETURNED. COMPLAINT HISTORY ANALYSIS - 48 COMPLAINTS HAVE BEEN RECEIVED RELATING TO DRAW ROD TIP DEFORMATIONS ON THIS DRIVER. INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER ERROR I.E. OVER-ANGULATION OF DRAW ROD WHEN CONNECTED TO SCREW, INSUFFICIENT DEPTH OF SCREWING BETWEEN DRAW ROD AND SCREW. FOR FOUR OF THOSE COMPLAINTS, FAILURE WAS REPORTED TO HAVE OCCURRED DURING SCREW INSERTION WHICH SURGICAL TECHNIQUE EXPLICITLY WARNS NOT TO DO. MFG RECORD REVIEW - NO RELEVANT DEVIATIONS REPORTED. RISK REVIEW - DRAW ROD IS MADE OF BIOCOMPATIBLE STAINLESS STEEL TO MITIGATE RISK OF BROKEN TIPS REMAINING INSIDE THE PT. CONCLUSION: THE DEFECTS ARE BELIEVED TO BE THE RESULT OF USER-ERROR. WHILE THE REVISION DRIVER IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT SHOULD BE AVOIDED AS THIS CAN CAUSE THE DRAW ROD TIP TO BEND OR BREAK. IN ORDER TO AVOID THE RIST OF DRAW ROD TIP BREAKAGE, THE REVISION DRIVER MUST BE AXIALLY ALIGNED WITH THE SCREW TRAJECTORY AND FULLY SEATED IN THE SCREW HEAD BEFORE INSERTING OR TIGHTENING THE DRAW ROD. NO CAPA IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BROKE DURING SCREW REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 109526

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK