BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 4465040 · Received January 20, 2015

    Report

    Report Number
    2020601-2015-00001
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 12, 2014
    Report Date
    January 13, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTY
    PMA / PMN Number
    K863734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INDICATION OF PATIENT INJURY DUE TO A FRACTURED BONE, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA. PER (B)(6), THEY ARE NOT SURE WHICH LOT NUMBER WAS INVOLVED WITH THIS CASE. BASED ON THIS, WE DID NOT SHOW A LOT NUMBER OR EXPIRATION DATE. THE FACILITIES HAS TWO LOT NUMBERS AS SHOWN BELOW: LOT #1114257636; EXPIRATION DATE 11/2018 AND LOT #0414243283; EXPIRATION DATE: 04/2018.

    Description of Event or Problem · 1

    BUNION SURGERY WAS PERFORMED IN THE OPERATING ROOM OF AMBULATORY FOOT AND LEG SURGERY CENTER, AN OUTPATIENT FACILITY. DURING SURGERY, PATIENT SUSTAINED A FRACTURED BONE IN THE FOOT. PATIENT WAS GIVEN PROTECTIVE FOOTWEAR (A STIFF-SOLED SANDAL) TO STABILIZE THE FOOT. SURGEON FEELS THE K-WIRES ARE NOT AS FLEXIBLE AS THEY ONCE WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44847 MICROAIRE K-WIRE, THREADED (KIRSCHNER WIRE) HTY MICROAIRE SURGICAL INSTRUMENTS, LLC 1600-662T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention