BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 5018708 · Received August 12, 2015

    Report

    Report Number
    2020601-2015-00063
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    April 16, 2015
    Report Date
    August 10, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K060249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SHOWED INDICATIONS OF IMPACT TO DEVICE DURING HANDLING (MISHAP) AS CAUSE. DUE TO INDICATION OF ITEM BREAKING DURING PROCEDURE, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    MICROAIRE WAS NOTIFIED ON (B)(6) 2015, OF A FIXATION DEVICE THAT REPORTEDLY BROKE DURING PROCEDURE. INFORMATION INDICATES THAT DOCTOR WAS ABLE TO USE A BACKUP DEVICE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529492 MICROAIRE FIXATION DEVICE HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-23202 266263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other