BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNCOMPSCREW 3.0MM (SELFDRILL)

    MDR report key: 11735009 · Received April 27, 2021

    Report

    Report Number
    2031009-2021-00002
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 27, 2021
    Manufacturer
    TRIMED INC
    Product Code
    HWC
    UDI-DI
    00842188103209
    PMA / PMN Number
    K050681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN INSPECTED AND IS WITHIN TRIMED'S SPECIFICATIONS.

    Description of Event or Problem · 1

    A TRIMED SALES REPRESENTATIVE REPORTED ON 30 MAR 2021 THAT THE L3034 THAT WAS IMPLANTED IN PATIENT (B)(6) ON (B)(6) 2020 HAD TO BE REMOVED. THE SCREW WAS CAUSING SOME PAIN IN THE BOTTOM OF THE PATIENT'S FOOT WHICH LED TO THE SCREW BEING REMOVED. IT WAS REPORTED THAT THE PATIENT WAS FULLY HEALED FROM THE INITIAL SURGERY IN SEPTEMBER BUT THE SCREW HAD MIGRATED FROM ITS ORIGINAL LOCATION CAUSING THE PAIN. IT WAS ALSO STATED THAT THE SURGEON USED A COUNTERSINK UNDER POWER IN THE ORIGINAL SURGERY, LIKELY CAUSING THE SCREW TO MIGRATE. TRIMED SURGICAL INSTRUMENTS LC-73-0004-014-USA REV F STATES, "TRIMED DRIVER SHAFTS, COUNTERSINKS AND TAPS MUST BE CONNECTED TO A HAND-HELD, MANUALLY OPERATED HANDLE, AND ARE NOT ADVISED TO BE PLACED UNDER POWER EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627688 CANNCOMPSCREW 3.0MM (SELFDRILL) CANNCOMPSCREW 3.0MM (SELFDRILL) HWC TRIMED INC L3034 00842188103209

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention