BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE II T-TIP

    MDR report key: 3171728 · Received June 16, 2013

    Report

    Report Number
    2953769-2013-00086
    Event Type
    Malfunction
    Date Received
    June 16, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 9, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS THE TIP DOES NOT ARTICULATE. THE MECHANISM FUNCTIONS PROPERLY AT 0, 30, 45 AND 90 DEGREES. VISUAL ANALYSIS INDICATES THAT THE SCORE LINE IS BROKEN. VISUALLY THERE IS NO OTHER APPARENT DAMAGE. THE REPORTED COMPLAINT OF A CURETTE BREAK WAS CONFIRMED DURING TESTING; HOWEVER, THE TIP WAS INTACT. THE CURETTE SCORE LINE WAS BROKEN. THERE WAS NO OTHER ISSUE OBSERVED. THE DEVICE FAILED AS INTENDED BY DESIGN. THE SCORE LINE IS DESIGNED TO SEPARATE WHEN THE PHYSICIAN ROTATES THE HANDLE AND EXCEEDS A PREDETERMINED TORQUE VALUE. SEPARATION AT THE SCORE LINE LIMITS THE AMOUNT OF TORQUE APPLIED TO THE DISTAL END OF THE CURETTE, WHICH MINIMIZES THE LIKELIHOOD OF A DEVICE FAILURE TO OCCUR, SUCH AS THE BENDING OR BREAKING OF DISTAL TIP. THIS IS CONSISTENT WITH EXCEEDING THE DESIGN LIMITS OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION: HOSPITAL. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CURETTE "RUPTURED" AND HAD TO BE REPLACED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272726 CURETTE II T-TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH KYPHON NEUCHATEL 0005949543

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR