BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER

    MDR report key: 2921901 · Received January 15, 2013

    Report

    Report Number
    9617544-2013-90031
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, RISK ASSESSMENT, DEVICE HISTORY REVIEW, VISUAL INSPECTION. RESULTS: THERE HAVE BEEN 2 COMPLAINTS RELATED TO TIP DEFORMATION FOR THIS PRODUCT. THE PRODUCT WAS RETURNED AND IT WAS CONFIRMED THAT THE TIP FRACTURED. THE BROKEN TIP WAS NOT RETURNED. THE DHR FOR THIS DEVICE' BATCH WAS REVIEWED AND NO DEVIATIONS WERE REPORTED. IN THIS CASE THERE WERE NO ADVERSE EVENTS REPORTED AND THE SURGERY WAS COMPLETED. THERE ARE ADDITIONAL INSTRUMENTS IN THE KIT THAT CAN BE USED TO COMPLETE THE SURGERY. CONCLUSION: THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE BREAKAGE COULD HAVE OCCURRED IF THE USER PIVOTED OR ANGULATED THE INSTRUMENT WHEN IT WAS ATTACHED TO THE SCREW. EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SURGEON WAS INSERTING AVIATOR SCREW, AS HE WAS DOING THE FINAL TURN TO SET SCREW WE HEARD A POP SOUND. THE SURGEON PULLED THE SCREWDRIVER OUT AND WE NOTICED THAT THE TIP OF THE INNER SHAFT WAS MISSING. DR ZOOMED IN WITH MICROSCOPE AND WE SAW THE TIP STILL INSIDE THE SCREW. WE REMOVED SCREW WITH THE REMOVAL INSTRUMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22401 AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER INSTRUMENT KWP STRYKER SPINE BORDEAUX NA 103119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK