BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM X 16MM ARSENAL LOCKING SCREW

    MDR report key: 19464346 · Received June 4, 2024

    Report

    Report Number
    3007420745-2024-00003
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 4, 2024
    Manufacturer
    TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE
    Product Code
    HWC
    UDI-DI
    00810028391154
    PMA / PMN Number
    D356720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "10 HOLE LATERAL FIB PLATE LEFT (300-93-005). 2ND MOST DISTAL HOLE, ANTERIORLY. FIRST SCREW 3.5X16 LOCKING (308-35-016) CAUSED "CURLY CUES" OFF OF IT AND SPUN IN THE PLATE. A 2ND SCREW SAME SIZE WAS PUT IN, NO CURLY CUES BUT SEATED BETTER. HOWEVER DIDN'T HAVE A HARD LOCK INTO PLATE. LEFT 2ND SCREW IN PLATE." ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "10 HOLE LATERAL FIB PLATE LEFT (300-93-005). 2ND MOST DISTAL HOLE, ANTERIORLY. FIRST SCREW 3.5X16 LOCKING (308-35-016) CAUSED "CURLY CUES" OFF OF IT AND SPUN IN THE PLATE. A 2ND SCREW SAME SIZE WAS PUT IN, NO CURLY CUES BUT SEATED BETTER. HOWEVER DIDN'T HAVE A HARD LOCK INTO PLATE. LEFT 2ND SCREW IN PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823294 3.5MM X 16MM ARSENAL LOCKING SCREW SCREW, FIXATION, BONE HWC TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE UNKNOWN 00810028391154

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female 300-93-005 LOT: UNKNOWN