BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM X 16MM LKG VARIABLE ANGLE SCREW

    MDR report key: 18179410 · Received November 20, 2023

    Report

    Report Number
    3025141-2023-00671
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    August 2, 2023
    Report Date
    November 18, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    PMA / PMN Number
    K120903
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE BATCH/LOT UNMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 08 AUGUST 2023, A PART NUMBER 80-1008 TORQUE LIMITING DRIVER WAS RETURNED WITH A NOTE STATING IT WAS MALFUNCTIONING. NO FURTHER INFORMATION WAS PROVIDED, AND FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE PERFORMED TO NO AVAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOVEMBER 203: IT WAS REPORTED DURING SURGERY, WHILE USING THE PART NUMBER 80-1008 TORQUE LIMITING DRIVER TO IMPLANT THE 2.3 DISTAL SCREWS IN THE ACULOC PLATE, THE 80-1008 WAS NOT WORKING PROPERLY AS IT WAS STRIPPING SCREWS. SWITCHING TO AN OLDER GENERATION "ORANGE HANDLE" 80-1008 TORQUE LIMITING DRIVER RESOLVED THE ISSUE. TO COMPLETE THE SURGERY, THE STRIPPED SCREWS WERE REMOVED, AND NEW SCREWS WERE IMPLANTED USING THE "ORGANGE HANDLE" 80-1008. IT WAS REPORTED THIS ISSUE PROLONGED THE SURGERY BY 10-15 MINUTES AND RESULTED IN LONGER TIME UNDER ANESTHESIA FOR THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00670 AND 3025141-2023-00672 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069745 2.3MM X 16MM LKG VARIABLE ANGLE SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC 30-2316

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown