BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEZ LONG HANDLE MINI PIN & LIGATURE CUTTER

    MDR report key: 2946742 · Received February 6, 2013

    Report

    Report Number
    2016150-2013-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    November 1, 2012
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DETAILS WITH REGARD TO AGE, GENDER, AND WEIGHT WERE NOT PROVIDED. IT WAS CONFIRMED THAT NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT; THE BROKEN PIECE WAS COLLECTED IMMEDIATELY. THE PATIENT WAS NOT HARMED AND IS DOING FINE.A VISUAL TEST WAS PERFORMED ON THE RETURNED DEVICE CONFIRMING THAT THE CUTTING SURFACE HAD BROKEN AWAY FROM THE TIP AND A BRAZE FAILURE HAD OCCURRED; HOWEVER, THE CAUSE OF THE BREAKAGE WAS INCONCLUSIVE. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT NUMBER.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE BLADE FROM AN AEZ MINI LIGATURE CUTTER HAD BROKEN OFF OF THE DEVICE DURING A PATIENT'S PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51247 AEZ LONG HANDLE MINI PIN & LIGATURE CUTTER LIGATURE WIRE CUTTER EJB ORMCO CORPORATION 08H10H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other