BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 2363913 · Received November 17, 2011

    Report

    Report Number
    9617544-2011-00385
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - COMPLAINT HISTORY ANALYSIS, RISK ASSESSMENT, PHOTOGRAPHIC INSPECTION. RESULTS - THERE HAVE BEEN 29 TOTAL COMPLAINTS RELATED TO INNER SHAFT TIP DEFORMATION; THOSE INVESTIGATIONS CONCLUDED THAT USER-ERROR LEAD TO THE FAILURES. A PHOTO OF THE IMPLICATED INSTRUMENT WAS SENT TO STRYKER SPINE AND IT CONFIRMED THAT THE TIP IS MISSING. THE DEVICE IS MADE OF AN IMPLANT GRADE STAINLESS STEEL TO MITIGATE ANY RISKS OF TIPS REMAINING IN THE PT. IN THIS CASE, THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 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

    (B)(6) WAS ATTEMPTING TO REMOVE A BONE SCREW FROM REFLEX HYBRID PLATE WITH THE EXTRACTION DRIVER. THE FIRST TROCHAR DID SCREW INTO THE BONE SCREW. AS SOON AS AN ATTEMPT WAS MADE TO REMOVE THAT BONE SCREWS FROM THE REFLEX HYBRID PLATE THE SCREW DRIVER TOGGLED OUT OF THE SCREW. AT THIS POINT, THE INNER TROCHAR WAS INSPECTED AND FOUND TO HAVE NO THREAD. THE DEVICE WAS USED CORRECTLY. THE SECOND SUPPLIED TROCHAR ON THE KIT WAS CALLED FOR. THIS ALSO HAD NO THREAD. NO ATTEMPT WAS MADE TO USE THE SECOND TROCHAR. GOLD LOCKING SCREW DRIVER WAS USED TO BACK THE SCREWS OUT TOGETHER FROM THE REFLEX HYBRID PLATE. THERE WAS A DELAY OF 25 MINUTES IN SURGERY AS A RESULT BUT NO MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR