BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    MICROAIRE K-WIRE

    MDR report key: 15480611 · Received September 24, 2022

    Report

    Report Number
    2020601-2022-00006
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    July 14, 2022
    Report Date
    March 2, 2023
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HXS
    UDI-DI
    00847399001429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A 28 YEAR OLD REQUIRED SURGERY OF THE RIGHT HAND TO ADDRESS A 5TH METACARPAL FRACTURE ON (B)(6) 2022. AT A POST OPERATIVE APPOINTMENT THER WAS SIGNIFICANT EDEMA NOTH THROUGHOUT THE DORSAL ASPECT OF THE RIGHT HAND. ADDITIONAL MRI IMAGING WAS CONCERNING FOR OSTEOMYELITIS. PATIENT WAS PRESCRIBED AN ADDITONAL ANTIBIOTIC TO TAKE FOR 28 DAYS DURING A TRIP ABROAD AND PATIENT WAS TO RETURN FOR ANOTHER POST OPERATIVE CHECK UPON HIS RETURN TO THE STATES. MICROAIRE SURGICAL INSTRUMENTS, LLC WOULD LIKE TO NOTE THAT ANOTHER INCIDENTY WITH ANOTHER PATIENT RESULTED IN AN INFECTION THAT REQUIRED MRI IMAGINGS, DEBRIDEMENT SURGERY, ORAL ANTIOBIOTIC TREATMENT, AND 6 WEEKDS OF IV ANTIBIOTIC TREATMENT FOR OSTEOMYELITIS. THE PRIOR INCIDENT WAS ON MICROAIRE REPORT 2020601-2022-00005. BOTH PATIENTS WERE TREATED BY DR. RYAN TARR AT ORTHONC ASC.

    Description of Event or Problem · 0

    A 28 YEAR OLD REQUIRED SURGERY OF THE RIGHT HAND TO ADDRESS A 5TH METACARPAL FRACTURE ON (B)(6) 2022. AT A POST OPERATIVE APPOINTMENT THERE WAS SIGNIFICANT EDEMA THROUGHOUT THE DORSAL ASPECT OF THE RIGHT HAND. ADDITIONAL MRI IMAGING WAS CONCERNING FOR OSTEOMYELITITS. PATIENT WAS PRESCRIBED AN ADDITIONAL ANTIBIOTIC TO TAKE FOR 28 DAYS DURING A TRIP ABROAD AND PATIENT WAS TO RETURN FOR ANOTHER POST OPERATIVE CHECK UPON HIS RETURN TO THE STATES. MICROAIRE SURGICAL INSTRUMENTS, LLC WOULD LIKE TO NOTE THAT ANOTHER INCIDENT WITH ANOTHER PATIENT RESULTED IN AN INFECTION THAT REQUIRED MRI IMAGINGS, DEBRIDEMENT SURGERY, ORAL ANTIBIOTIC TREATMENT, AND 6 WEEKS OF IV ANTIBIOTIC TREATMENT FOR OSTEOMYELITIS. THE PRIOR INCIDENT WAS ON MICROAIRE REPORT 2020601-2022-00005. BOTH PATIENTS WERE TREATED BY DR. RYAN TARR AT ORTHONC ASC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580301 MICROAIRE K-WIRE K-WIRE 1.1MM(0.045")X152MM(6"), HXS MICROAIRE SURGICAL INSTRUMENTS, LLC 1600-645 1021364293 00847399001429

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other