BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, 2.0MM (AO)

    MDR report key: 17161594 · Received June 20, 2023

    Report

    Report Number
    1220246-2023-06935
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 24, 2023
    Report Date
    February 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867052840
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    CORRECTED INFORMATION: B5 DATE WAS CORRECTED FROM 6/31/2023 TO 5/31/2023. ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 2) OF AN AR-8944-22 DRILL BIT BROKE DURING A CASE WITH A SLIGHT CASE DELAY OF APPROXIMATELY 5 MINUTES TO RETRIEVE ANOTHER BIT. THE DEVICE BROKE WITHIN THE PATIENT, BUT THEY COULD RETRIEVE ALL FRAGMENTS AND COMPLETE THE PROCEDURE. ONE OF THE INCIDENTS HAPPENED YESTERDAY, AND ANOTHER WITH A DIFFERENT SURGEON TODAY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/31/2023: THIS WAS DISCOVERED DURING A PATELLA TENDON RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE AR-8944-22 DRILL BIT BROKE WHEN DRILLING TUNNELS. THE CASE WAS COMPLETED BY OPENING A STERILE 2.0 DRILL NON-ARTHREX PRODUCT. THERE WERE NO PICTURES TAKEN OF THE DEVICE..

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/31/2023: THIS WAS DISCOVERED DURING A PATELLA TENDON RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE AR-8944-22 DRILL BIT BROKE WHEN DRILLING TUNNELS. THE CASE WAS COMPLETED BY OPENING A STERILE 2.0 DRILL NON-ARTHREX PRODUCT. THERE WERE NO PICTURES TAKEN OF THE DEVICE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528020 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