BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT

    MDR report key: 2981419 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-01217
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Product Code
    DZK
    PMA / PMN Number
    K982222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A SACRO ILIAC SCREW IMPLANT PROCEDURE THE THREADED GUIDE WIRE CALIBRATION LINE WAS RUBBED OFF AFTER INSERTION BY THE WIRE DRIVER MAKING THE MEASUREMENT WITH A DEPTH GAUGE UNATTAINABLE. A REPLACEMENT THREADED GUIDE WIRE WAS PLACED ALONG SIDE THE INSERTED GUIDEWIRE TO OBTAIN PROPER MEASUREMENT FOR SCREW SIZE. NO DELAY TO PROCEDURE NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85677 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT DZK

    Patients

    Seq Age Sex Outcome Treatment
    1