BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM X 8MM BONE MANIPULATION SCREW

    MDR report key: 23116389 · Received September 22, 2025

    Report

    Report Number
    2027754-2025-00050
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 22, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT RECEIVED 220-0729: BONE MANIPULATION SCREW, 2.4 MM X 8 MM WAS IN VISUALLY INSPECTED THROUGH PACKAGING DUE TO THE FACT WAS CLEANED BUT NOT STERILIZED. DUE TO THE FACT THE PN WAS NOT VISIBLE THE PACKAGE WAS OPENED AND A PICTURE OF THE PN WAS TAKEN, THE BREAKAGE OCCURRED 2 THREADS BEFORE THE THREAD PULL-OUT OF THE SCREW, AND AT THIS MOMENT THE ROOT CAUSE CANNOT BE ESTABLISHED. BOTH PIECES WERE PACKAGED BACK AND LABELED. NO ACTION ITEMS ARE RECOMMENDED CURRENTLY AND CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS UTILIZING THE "BONE MANIPULATION SCREW" TO REDUCE A FRACTURED ZYGOMA WHEN THE TIP BROKE OFF IN THE PATIENTS ZYGOMA. WE SPENT APPROXIMATELY 10 MIN TO EXTRACT THE TIP FROM THE BONE. THE CASE CONTINUED ON AFTER THAT WITHOUT INCIDENT. (REPORTED DELAY OF 10-15 MINUTES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200955 2.4MM X 8MM BONE MANIPULATION SCREW SCREW, FIXATION, BONE HWC OSTEOMED, LLC 220-0729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown