BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2896741 · Received December 28, 2012

    Report

    Report Number
    9617544-2012-00608
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - VISUAL INSPECTION, MFG RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: AFTER VISUAL INSPECTION, THE THREADED TIP OF THE RETURNED REFLEX-HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR WAS CONFIRMED TO BE BROKEN. MFG RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MFG. COMPLAINT HISTORY ANALYSIS: (B)(4) PREVIOUS RECORDS HAVE BEEN RECEIVED INVOLVING 115 UNITS. INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR, IE, 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 ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THE REPORTED EVENT. THE INSTRUMENT TIP IS MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PT. IN THE ABSENCE OF THE REFLEX-HYBRID REVISION DRIVER, THE REFLEX-HYBRID SCREW EXTRACTOR CAN BE USED TO EXTRACT SCREWS. CONCLUSION: IT 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 A REVISION SURGERY OF A REFLEX HYBRID PLATE. REVISION DRIVER ((B)(4)) WAS SEATED IN THE FIRST SCREWHEAD AND THREADED INTO THE SCREW CANNULATION. DURING THE PROCESS OF BACKING OUT THE SCREW THE DRIVER CAME LOOSE FROM THE SCREW. UPON EXAMINATION OF THE INNER SHAFT OF THE DRIVER, THE PHYSICIAN NOTICED THAT THE TIP OF THE INNER SHAFT OF THE REVISION DRIVER HAD BROKEN OFF INSIDE THE SCREW. A DIFFERENT REVISION DRIVER WAS THEN USED TO REMOVE THE REMAINDER OF THE SCREWS AND ULTIMATELY THE PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT NKB STRYKER SPINE BORDEAUX NA 119317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK