BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRUT PICK, .50MM PT.,90 DEG ANG,MED 1/E

    MDR report key: 2232139 · Received September 2, 2011

    Report

    Report Number
    1045254-2011-00064
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    April 12, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT KNOWN BY REPORTER. THE CUSTOMER DID NOT HAVE THE PRODUCT LOT NUMBER. INSTRUMENT WILL NOT BE RETURNED TO THE MANUFACTURER. AN OTO PICK IS USED FOR A VARIETY OF EAR PROCEDURES, MOST COMMONLY IN MIDDLE EAR PROCEDURES. IT IS LONG AND NARROW WITH A VERY FINE TIP. SOME PICKS HAVE A SLIGHT ANGLE AT THE TIP FOR BETTER ACCESS TO THE ANATOMY OF THE EAR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE UNDERGOING AN EAR PROCEDURE, THE TIP OF AN OTO PICK INSTRUMENT BROKE OFF IN A PATIENT'S EAR. ANOTHER MAGNETIZED INSTRUMENT WAS USED TO RETRIEVE THE METAL TIP. NO INJURY OR SEQUELLA REPORTED. LONG TERM PROGNOSIS WAS REPORTED AS GOOD. THE CUSTOMER DID NOT KNOW IF THE PRODUCT BROKE IN THE OUTER OR INNER EAR. IT WAS ALSO REPORTED THAT THE FRAGMENT WAS RETRIEVED QUICKLY AND WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRUT PICK, .50MM PT.,90 DEG ANG,MED 1/E PICK, MICROSURGICAL EAR JYT MEDTRONIC XOMED INC. 3722062 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR