BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM TICANN COMPRESSION HEADLESS CREW LT 28MM

    MDR report key: 12189374 · Received July 19, 2021

    Report

    Report Number
    3012966183-2021-00017
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 19, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917023190
    PMA / PMN Number
    K170571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PARTIALLY REMOVED PRODUCT WAS NOT RETURNED FOR EVALUATION THE ROOT CAUSE IS INDETERMINATE. THERE ARE NO CAPAS, NON-CONFORMANCES, OR ESTABLISHED TRENDS ON THIS PART NUMBER /COMPLAINT TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TITANIUM CANNULATED COMPRESSION HEADLESS SCREW BROKE IN THE HUMERUS OF PATIENT. THE SURGEON LEFT THE THREADED PORTION IN BONE. HEAD PORTION WAS REMOVED EASILY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091054 2.0MM TICANN COMPRESSION HEADLESS CREW LT 28MM HEADLESS SCREW HWC TYBER MEDICAL 04.334.028 00819917023190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other