BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30MM DRILL

    MDR report key: 21000894 · Received December 23, 2024

    Report

    Report Number
    1220246-2024-09018
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 27, 2024
    Report Date
    September 15, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    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 USER ERROR OF THE DEVICE DUE TO IMPROPER DETERGENT/CLEANING PROCESS USED.

    Description of Event or Problem · 0

    ON 11/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9620-30D DRILL HAD BONE STUCK IN IT AND WAS UNABLE TO BE USED. AND AN AR-9618-24, AND AR-9618-24 REAMER ARE DULL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628480 30MM DRILL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. 30MM DRILL 25672225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown