BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2588367 · Received May 23, 2012

    Report

    Report Number
    9617544-2012-00201
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 26, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION , MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: VISUAL INSPECTION: THE THREADED TIP OF THE RETURNED REFLEX-HYBRID REVISION DRIVER DRAW ROD WAS CONFIRMED TO BE BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED. MANUFACTURING RECORD REVIEW: NO DISCREPANCIES NOTED. BATCH 100801 COMPLIED WITH DIMENSIONAL, APPEARANCE AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. COMPLAINT HISTORY ANALYSIS: A TOTAL OF 77 COMPLAINTS INVOLVING 80 UNITS HAVE BEEN RECEIVED RELATING TO DRAW ROD TIP DEFORMATIONS ON THE REFLEX-HYBRID REVISION DRIVER. 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. RISK ASSESSMENT: NO ADVERSE CONSEQUENCES REPORTED. NOTE: THE REFLEX-HYBRID REVISION DRIVER DRAW ROD IS MADE OF IMPLANT GRADE BIOCOMPATIBLE STAINLESS STEEL TO MITIGATE THE RISK OF BROKEN TIPS REMAINING INSIDE THE PT. CONCLUSION: THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT WHILE THE REFLEX-HYBRID SCREW EXTRACTOR IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT SHOULD BE AVOIDED AS THIS CAN CAUSE BENDING OR BREAKING OF THE INNER SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DR (B)(6) BROKE 2 REVISION DRIVER DRAW RODS DURING A REFLEX HYBRID REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT KWP STRYKER SPINE BORDEAUX NA 100801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK