BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED COMPRESSION HEADLESS SCREW

    MDR report key: 22811861 · Received August 14, 2025

    Report

    Report Number
    3012966183-2025-00019
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 14, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    LXH
    UDI-DI
    00819917026566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS EVALUATED AND INVESTIGATED WITH THE PROVIDED INFORMATION. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS NO DEVICE LOT INFORMATION WAS RECEIVED. A HISTORICAL DATA ANALYSIS WAS CONDUCTED THAT IDENTIFIED NO TRENDS OR CAPAS RELATED TO THE NATURE OF THIS COMPLAINT. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ANNEX G CODE 4756 USED. THE IMPACTED DEVICE TERM SHOULD BE DRILL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025 WHILE DRILLING THROUGH THE 1ST MET, RESIDENT DOCTOR MENTIONED THAT THERE WASN'T FEELING LIKE THERE WAS MUCH POWER OR ANY ADVANCEMENTS WITH THE DRILL BIT. THE SURGEON ASSUMED IT WAS DUE TO THE NATURE OF THE PATIENT'S HARDER THAN AVERAGE BONE AS THE SURGEON HAD ALREADY GONE THROUGH 3 SAW BLADES PRIOR TO THIS INCIDENT. UPON PULLING THE DRILL BIT OUT OF THE TISSUE SLEEVE, THE RESIDENT NOTICED THE DRILL BIT HAD SNAPPED. UPON FLUORO, IT WAS DISCOVERED THAT THE TIP OF THE DRILL BIT HAD SNAPPED INTO ONE LARGE PIECE, AND 2 SMALLER PIECES WHILE ALSO DAMAGING THE DRILL SLEEVE WHEN PULLING OUT. THE SURGEON WAS ABLE TO REMOVE THE LARGE PIECE OF THE DRILL BIT BUT WAS UNABLE TO RECOVER THE 2 SMALLER FRAGMENTS THAT WERE STUCK WITHIN THE BONE/OSTEOTOMY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726636 CANNULATED COMPRESSION HEADLESS SCREW 2.0MM CANN DRILL BIT QC/ 145MM LXH TYBER MEDICAL 03.333.301 00819917026566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other