BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED COMPRESSION HEADLESS SCREW

    MDR report key: 23271610 · Received October 10, 2025

    Report

    Report Number
    3012966183-2025-00021
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 10, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    PMA / PMN Number
    K133842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS EVALUATED AND INVESTIGATED AIDED BY THE IMAGES AND INFORMATION PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. IMAGES WERE PROVIDED THAT CONFIRMED THE COMPLAINT EVENT, BUT FURTHER DETAILS WERE NOT MADE AVAILABLE REGARDING THE PLACEMENT OR HANDLING OF THE DEVICE PRIOR TO THE BREAK. A DHR REVIEW WAS CONDUCTED THAT CONFIRMED NO NONCONFORMITIES WERE PRESENT IN THE LOT RELATED TO THE NATURE OF THIS COMPLAINT AND THE LOT MET SPECIFICATIONS AT THE TIME OF RELEASE. NO TRENDS OR CAPAS ASSOCIATED WITH THE NATURE OF THIS COMPLAINT WERE IDENTIFIED THROUGH A HISTORICAL DATA ANALYSIS. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON B)(6) 2025 WHILE INSERTING SHORT THREAD 2.5MM CANNULATED COMPRESSION HEADLESS SCREW, THE SCREW BROKE OFF IN THE INTRAMEDULLARY CANAL OF A METACARPAL AT THE POINT WHERE THE THREADING BEGINS. THERE WAS 30 MINUTES OF DELAY. SCREW SHAFT WAS REMOVED FROM THE HEAD DOWN TO THE POINT WHERE THE THREADS WOULD HAVE STARTED LEAVING THE THREADED PORTION RETAINED WITHIN THE BONE. SURGEON REDIRECTED AND PLACED A STAINLESS STEEL PLATE INTERNALLY FOR DEFINITIVE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470534 CANNULATED COMPRESSION HEADLESS SCREW 2.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 40MM HWC TYBER MEDICAL 04.333.140 20342BB01

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other