BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE LOCKING SCREW, 2.7 X 14 MM

    MDR report key: 19436710 · Received May 31, 2024

    Report

    Report Number
    1220246-2024-04566
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 2, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K143614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS NOT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED NO ISSUES WITH THE SCREW. DIMENSIONAL TESTING REVEALS THAT THE SCREW MEETS THE DIMENSIONAL REQUIREMENTS PER DRAWING C1330-03. FUNCTIONAL TESTING WAS PERFORMED, AND THE SCREWS FIT PROPERLY AND WORKED AS REQUIRED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW. PER DFU-0125-EO REV 4 G PRECAUTIONS - 4. DAMAGE TO THE DRIVER OR SCREW MAY RESULT FROM FAILURE TO SEAT THE DRIVER FULLY INTO THE SCREW OR TO ALIGN THE DRIVER PROPERLY WITH THE SCREW.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE SCREW COULD NOT BE INSERTED INTO THE PLATE AR-2656DRS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332403 LOW PROFILE LOCKING SCREW, 2.7 X 14 MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LOW PROFILE LOCKING SCREW, 2.7 X 14 MM 15087252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown