BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED POLY SCREWDRIVER II-MOD

    MDR report key: 1032935 · Received April 23, 2008

    Report

    Report Number
    1649384-2008-00219
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVAL IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY, THE NURSE ATTACHED THE SCREW TO THE SCREWDRIVER. THE SCREW SEEMED WELL LOCKED WHEN IN FACT, THE EXTREMITY OF THE SCREWDRIVER WAS NOT INTRODUCED ONTO THE SCREW HEAD. IT APPEARED THAT IT WAS NOT POSSIBLE TO INTRODUCE THE SCREW DRIVER ONTO OTHER SCREWS. ADD'L INFO RECEIVED ON 23 APR 2008: THE DISTRIBUTOR REPORTED THAT THE SURGEON USED THE OTHER DRIVER WITHIN THE KIT TO FINISH THE CASE AS INTENDED. THERE WAS A 10 MINUTE DELAY IN SURGERY. THERE WAS NO REPORTED INJURY TO THE PT. THIS MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED POLY SCREWDRIVER II-MOD PATHFINDER HXX ABBOTT SPINE 47FE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK