BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 19783690 · Received July 19, 2024

    Report

    Report Number
    3025141-2024-00546
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    May 27, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED SCREW WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MODEL NUMBER AND BATCH/LOT NUMBER OF THE SCREW IS UNKNOWN. HOWEVER, THE REPORTED DRILL WAS RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE T8 STICK FIT HEXALOBE DRIVER (PART NUMBER 80-0729, BATCH NUMBER 597274) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE DRIVER SHOWED COUNTERCLOCKWISE TWISTING AT THE TIP, WHICH SUGGESTED THE DEFORMATION MAY HAVE OCCURRED DURING REMOVAL. A POSSIBLE CAUSE OF A TWISTING DEFORMATION IS EXCESSIVE TORQUE APPLIED TO THE PART. FUNCTIONAL TESTING WITH A 2.7MM HEXALOBE SCREW WAS PERFORMED, WHICH REVEALED THE DRIVER COULD STILL SEAT INTO THE SCREW HEAD. BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY WHEN THE SURGEON USED SCREWDRIVER TO REMOVE THE SCREW FROM THE PLATE, THE TIP OF THE SCREWDRIVER TWISTED AND DEFORMED. THE SURGEON SAID IT WAS EASILY DEFORMED, EVEN THOUGH HE DID NOT ROTATE THE SCREWDRIVER WITH THAT MUCH FORCE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE OF THE SAME MODEL AFTER A 5-MINUTE DELAY. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2024-00545 FOR THE DRIVER INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673139 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown