BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM X 16MM LKG VARIABLE ANGLE SCREW

    MDR report key: 20444701 · Received October 14, 2024

    Report

    Report Number
    3025141-2024-00664
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE 2.3MM X 16MM LKG VARIABLE ANGLE SCREW WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE 2.3MM X 16MM LKG VARIABLE ANGLE SCREW (PART NUMBER 30-2316) BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY, THE SURGEON WAS IMPLANTING A 2.3 VARIABLE ANGLE SCREW AND TIGHTENING IT DOWN IN THE FINAL TURNS WHEN THE DRIVER TIP BROKE. THE SURGEON TRIED TO GET THE TIP OUT BUT FAILED. THE TIP WAS LEFT IN THE PATIENT AND THE DOCTOR BURRED THE TIP FLUSH WITH THE SCREW. THE SURGERY WAS COMPLETED AFTER A 30 DELAY WHICH INCREASED THE PATIENTS TIME UNDER ANESTHESIA. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2024-00663 FOR THE DRIVER INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208589 2.3MM X 16MM LKG VARIABLE ANGLE SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC 30-2316

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female