BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2772275 · Received October 2, 2012

    Report

    Report Number
    9617544-2012-00418
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: COMPLAINT HISTORY ANALYSIS: (B)(4). INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR I.E. OVER-ANGULATION. 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". RISK ASSESSMENT: THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THE INSTRUMENT BREAKAGE. THE REFLEX-HYBRID REVISION DRIVER DRAW ROD TIP IS MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PT. CONCLUSION: A THOROUGH INVESTIGATION COULD NOT BE PERFORMED DUE TO THE UNAVAILABLE OF THE IMPLICATED DEVICE AND LACK OF INFO INCLUDING COMPLAINTS, THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT CANTILEVERING THE INSTRUMENT MAY DAMAGE THE TIP OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING REMOVAL DRAW ROD TIP BROKE OFF."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK