BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER USA K-WIRES SMOOTH

    MDR report key: 10763959 · Received October 30, 2020

    Report

    Report Number
    2025102-2020-00001
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    HTY
    PMA / PMN Number
    K945670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INVESTIGATION: THE PRODUCT WAS RETURNED TO BRASSELER FOR INVESTIGATION. BRASSELER TESTED THE RETURNED PRODUCT AND REVIEWED SOURCE DOCUMENTS AND CONCLUDE: THE PRODUCT DIAMETER WAS WITHIN SPECIFICATION. ANOTHER PART WAS TESTED FROM THE SAME MFG. LOT AND MET ALL DIMENSIONAL SPECIFICATIONS. SOURCE DOCUMENTS CONFIRMED THE PRODUCT MEETS OR EXCEEDS THE REQUIREMENTS OF ASTM F138-13 FOR TENSILE STRENGTH. THE RETURNED PRODUCT EXHIBITED GOUGING AROUND THE CIRCUMFERENCE OF THE K-WIRE AND HAS A NOTICEABLE BEND. THE IDENTIFIED GOUGING WAS MOST LIKELY CAUSED BY EXCESSIVE LATERAL FORCE. THE INVESTIGATION CONCLUDES THAT THIS IS AN ISOLATED INCIDENT AND WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    THE DOCTOR WAS DRILLING 6" .062 SINGLE TROCAR K WIRE INTO A YOUNGER PATIENT AND THE WIRE SNAPPED BELOW THE BONE SURFACE. THE DOCTOR DECIDED TO NOT REMOVE THE WIRE DUE TO THE INTRUSION OF BURRING OUT BONE CLOSE TO THE GROWTH PLATE. OPERATING ROOM (OR) STAFF EXPLAINED THAT THE WIRE WAS NOT BEING BENT MORE THAN USUAL AND THE WIRE SEEMED TO SNAP UNDER LITTLE PRESSURE. SINCE THE WIRE SNAPPED BELOW THE SURFACE OF THE BONE, NO FOLLOW UP WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226412 BRASSELER USA K-WIRES SMOOTH SINGLE TROCAR K-WIRE HTY BRASSELER U.S.A. MEDICAL, LLC KM172-16-62S NT1WK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Disability