BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER

    MDR report key: 3852816 · Received June 6, 2014

    Report

    Report Number
    0009617544-2014-00261
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE LIKELY CAUSES OF THE TIP FRACTURE WAS A CANTILEVER LOAD APPLIED DURING SCREW INSERTION AND/OR INSTRUMENT AGE. THIS CANTILEVER LOAD IS POSSIBLE IF THE DRIVER WAS NOT FULLY SEATED INTO THE SCREW HEAD DURING INSTALLATION OF THE DRAW ROD, AS IDENTIFIED IN THE SURGICAL TECHNIQUE. THE INSTRUMENT WAS FOUND TO BE MANUFACTURED APPROXIMATELY 4 YEARS AGO. CONCLUSION: THE AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER WAS CONFIRMED TO HAVE THE DISTAL TIP SHEARED OFF. MANUFACTURING FILES WERE REVIEWED AND NO ISSUES WERE FOUND. THERE WAS NO HARM IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE DURING SCREW INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE DURING SCREW INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332130 AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER IMPLANT-RESCUE SCREWDRIVER LXH STRYKER SPINE-FRANCE RETRIEVING FROM HOSPITAL, WILL

    Patients

    Seq Age Sex Outcome Treatment
    1