BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 9826325 · Received March 12, 2020

    Report

    Report Number
    3008480376-2020-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 12, 2020
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Product Code
    JDS
    PMA / PMN Number
    K141737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. FOLLOW-UP REPORT(S) WILL BE SUBMITTED UPON OBTAINING ANY ADDITIONAL INFORMATION. CONVENTUS ORTHOPAEDICS, INC. ATTEMPTED TO SUBMIT THIS MDR ON FEBRUARY 26, 2020 AT 4:12PM. HOWEVER, A NEW (B)(6) ACCOUNT NEEDED TO BE CREATED AND WAS NOT APPROVED UNTIL (B)(6) 2020. AS SUCH, THIS MDR IS BEING SUBMITTED LATE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE SURGEON REMOVED PH SYSTEM HARDWARE. DURING THE SURGERY, THE TIP OF TWO 120MM H10 DRIVERS AND ONE 160MM H10 DRIVER BROKE OFF INTO THE HEADS OF THE SCREWS. CONVENTUS ORTHOPAEDICS, INC. IS SUBMITTING THREE SEPARATE MDRS FOR EACH OF THESE THREE BREAKAGE EVENTS. THIS MDR IS REGARDING THE FIRST OF THE TWO 120MM H10 DRIVERS (MODEL NO. 7768-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291060 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC. 7768-1

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other