BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, 2.0MM, SHORT (AO)

    MDR report key: 19497875 · Received June 10, 2024

    Report

    Report Number
    1220246-2024-05368
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    March 21, 2023
    Report Date
    June 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867385535
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 03/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18800-22 DRILL GUIDE COLD WELDED WITH THE AR-18800-18 DRILL BIT. THIS OCCURRED DURING A CASE ON (B)(6) 2023, THE CASE PROCEEDED WITH A SECOND AR-18800-18 DRILL BIT IN THE SET. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658357 DRILL BIT, 2.0MM, SHORT (AO) DRILL BIT HTW ARTHREX, INC. DRILL BIT, 2.0MM, SHORT (AO) 00888867385535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown