BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGABITER, UP CURVED TIP, 5.5MM X 2.5MM

    MDR report key: 13528605 · Received February 14, 2022

    Report

    Report Number
    1220246-2022-04467
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    December 19, 2021
    Report Date
    April 13, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867032743
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-41026 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE 723-4002 CUTTER HAD BROKEN OFF OF THE DEVICE. THE FRAGMENT WAS NOT RETURNED FOR ASSESSMENT. A PROBABLE CAUSE IS ATTRIBUTED TO USER-APPLIED MECHANICAL FORCES, SUCH AS THROUGH PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784130 MEGABITER, UP CURVED TIP, 5.5MM X 2.5MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. MEGABITER, UP CURVED TIP, 5.5MM X 2.5MM 11569024 00888867032743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown