BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 2801284 · Received October 17, 2012

    Report

    Report Number
    9617544-2012-00443
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 20, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, RISK ASSESSMENT, DEVICE HISTORY REVIEW, VISUAL INSPECTION. RESULTS: THERE HAVE BEEN (B)(4) TOTAL COMPLAINTS RELATED TO INNER SHAFT TIP DEFORMATION; THOSE INVESTIGATIONS CONCLUDED THAT USER-ERROR LEAD TO THE FAILURES. THE DEVICE WAS INSPECTED AND IT WAS CONFIRMED THAT THE TIP IS BROKEN. THE BROKEN TIP WAS NOT RETURNED. THE DHR FROM THIS DEVICE'S BATCH WAS REVIEWED AND NO DEVIATIONS WERE NOTED. IN THIS CASE IT WAS LATER REPORTED THAT ALL FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THE DEVICE IS MADE OF AN IMPLANT GRADE STAINLESS STEEL TO MITIGATE ANY RISKS OF TIPS REMAINING IN THE PATIENT. CONCLUSION: PREVIOUS INSTRUMENT FAILURES HAVE OCCURRED DUE TO USER-ERROR AND IT IS BELIEVED THAT IS THE CASE HERE AS WELL. THE SURGICAL TECHNIQUE STATES THAT PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED AS IT CAN LEAD TO BREAKING OF THE INNER SHAFT.

    Description of Event or Problem · 1

    THE ITEM HAD BEEN BROKEN MIDDLE SHAFT INSIDE REFLEX HYBRID SCREW EXTRACTOR DURING STAGE OF REMOVE SCREW FROM REFLEX PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT INSTRUMENT MAX STRYKER SPINE BORDEAUX NA 10A528

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK