BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMETRY ILIUM CURETTE

    MDR report key: 2864490 · Received December 6, 2012

    Report

    Report Number
    3008875054-2012-00004
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ZYGA TECHNOLOGY, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLUOROSCOPIC IMAGING INDICATED CURETTE USE APPEARED NORMAL DURING THE SURGICAL PROCEDURE; NO FINAL FLUORO SHOT WAS TAKEN. AFTER RETRACTION OF THE CUTTING ELEMENT A FLUORO IMAGE SHOWED THAT A PORTION OF THE CURETTE TIP STILL REMAINED IN THE JOINT. THE SURGEON WORKED FOR ABOUT 15 MINUTES TO REMOVE THE REMAINING PIECE USING SUCTION, IRRIGATION, AND VARIOUS INSTRUMENTS HOWEVER THE PIECE COULD NOT BE RETRIEVED AND WAS LEFT BEHIND. SUBSEQUENT STEPS FOR THE SURGICAL PROCEDURE WERE COMPLETED WITHOUT INCIDENT; NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMETRY ILIUM CURETTE MANUAL SURGICAL INSTRUMENT LXH ZYGA TECHNOLOGY, INC. ZYG-10071 110438

    Patients

    Seq Age Sex Outcome Treatment
    1