BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, 2.0MM (AO)

    MDR report key: 18826105 · Received March 4, 2024

    Report

    Report Number
    1220246-2024-01254
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 14, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867052840
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON THE 15TH FEBRUARY 2024 IT WAS ADVISED BY A SALES REP THAT AN AR-8944-22, (DRILL BIT, 2.0 MM) - BATCH# UNKNOWN WAS REPORTED AS THE SURGEON WAS USING THE 2MM DRILL AND IT SNAPPED OFF INSIDE THE DRILL HOLE WHEN DRILLING TO INSERT A 3MM CORTEX SCREW IN A MAXFORCE PLATE. THERE WAS A CASE AND PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194830 DRILL BIT, 2.0MM (AO) DRILL BIT HTW ARTHREX, INC. DRILL BIT, 2.0MM (AO) UNK 00888867052840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown