BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTETOME, ANGLED UP, 12MM

    MDR report key: 17863859 · Received October 3, 2023

    Report

    Report Number
    1220246-2023-08059
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 5, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867133846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    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-8970-13, BATCH 041439 WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION REVEALED THAT THE RECEIVED DEVICE'S BLADE TIP HAD NICKS AND WAS DAMAGED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE APPLYING EXCESSIVE FORCES THROUGH LEVERAGING/PRYING THE DEVICE.

    Description of Event or Problem · 0

    ON 9/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06022369 THAT AN AR-8970-13 OSTEOTOME, ANGLED UP 12 MM WAS DAMAGED. THE ITEM CAME FROM A SET AND WAS DISCOVERED DURING A CASE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466602 OSTETOME, ANGLED UP, 12MM ARTHROSCOPIC ACCESSORIES NBH ARTHREX, INC. OSTETOME, ANGLED UP, 12MM 041439 00888867133846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown