BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK 165MM 2.0MM 90DEG BLUNT [MXI/XOM]

    MDR report key: 3420610 · Received October 21, 2013

    Report

    Report Number
    9680837-2013-00487
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 2, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. THE BATCH NUMBER (LOT NUMBER) OF THE INSTRUMENT IS NOT KNOWN BUT THE DESIGN INDICATES THAT THE INSTRUMENT IS AT LEAST 10 YEARS OLD. (B)(4): THE TIP OF THE HOOK IS BROKEN. THE BROKEN FRAGMENT IS MISSING. THE OBSERVATION OF THE BREAKAGE ZONE HAS NOT HIGHLIGHTED ANY MANUFACTURING OR MATERIAL DEFECTS AND INDICATES THAT THE BREAK HAS BEEN SUDDEN. CONSIDERING THE AGE AND THE ABSENCE OF MANUFACTURING OR MATERIAL DEFECT, THE MOST PROBABLE CAUSE IS A WEAKENING OF THE INSTRUMENT DURING IT YEARS OF USE THAT HAS LED TO THE BREAKAGE OBSERVED WITH A SHOCK / CONSTRAINT DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL EXTREMITY OF THE HOOK BROKE INSIDE THE EAR CANAL DURING SURGERY. NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539852 HOOK 165MM 2.0MM 90DEG BLUNT [MXI/XOM] HOOK, MICROSURGICAL EAR JYL XOMED MICROFRANCE MFG MCO805 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1