BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS CURETTE

    MDR report key: 2112012 · Received June 2, 2011

    Report

    Report Number
    2953769-2011-00070
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RECEIVED 1 T-TIP CURETTE FOR EVALUATION. THE CURETTE REMAINS IN THE WORKING CANNULA AND CANNOT BE REMOVED. THE CANNULA IS TIGHT ON THE CURETTE SHAFT. IT IS UNKNOWN IF THE CURETTE SHAFT IS BENT. THE HEAD OF THE CURETTE SPLAYED THE PIVOT PIN IS DISCONNECTED FROM THE WELD JOINTS ON BOTH SIDES OF THE HEAD A FRACTURE OF THE HEAD ON THE RIGHT SIDE IS OBSERVED TORQUE RESET MECHANISM IS STILL IN WORKING CONDITION LEVER AND LOCKING SWITCH ARE STILL WORKING; HOWEVER, THE TIP DOES NOT ARTICULATE CONCLUSION: THE REPORTED COMPLAINT OF CURETTE RETRACTION DIFFICULTY WAS CONFIRMED WITH THE PRODUCT RETURN. THE CURETTE COULD NOT BE REMOVED FROM THE WORKING CANNULA AND THE CURETTE HEAD WAS DAMAGED. PROBABLE ROOT CAUSE: IT IS LIKELY THAT THE HEAD SPLAYED DUE TO TORSIONAL FORCES APPLIED BY THE USER. THIS WOULD PUT PRESSURE ON THE PIVOT PIN CAUSING IT TO DISCONNECT FROM THE WELD JOINTS. METHOD; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING A KYPHOPLASTY PROCEDURE AT LEVEL L1, THE EXPRESS CURETTE COULD NOT BE PULLED OUT OF THE WORKING CANNULA. IT APPEARED THE DISTAL END OF THE CURETTE HAD BROKE DURING THE PROCEDURE. THE CURETTE HAD TO BE PULLED OUT WITH THE WORKING CANNULA AT THE SAME TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS IS GOOD. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS CURETTE HTF MEDTRONIC SPINE LLC. 0005588523

    Patients

    Seq Age Sex Outcome Treatment
    1