BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNANITE® STAPLE DRILL BIT, CAL, 2.0

    MDR report key: 19380589 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03702
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    August 19, 2021
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867326200
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    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. COMPLAINT CONFIRMED, ONE DRILL BIT BROKE OFF AND THE DISTAL FRAGMENT REMAINED CONTAINED AND STUCK WITHIN THE FRILL GUIDE; WHILE THE OTHER DEVICE HAS HEAVY ABRASION MARKS ON THE OD NEAR THE DISTAL END. THE OD OF BOTH DEVICES MET SPECIFICATIONS. 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 8/19/2021 IT WAS REPORTED BY SALES REPRESENTATIVE VIA SEMS THAT AN AR-8717D-02 GOT STUCK IN THE DRILL GUIDE AR-8717G-02 SIDE "15" DURING A CASE. THIS OCCURRED AGAIN DURING ANOTHER PROCEDURE, WHERE AR-8717D-02 GOT STUCK IN THE DRILL GUIDE AR-8717G-02 SIDE "13". NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452328 DYNANITE® STAPLE DRILL BIT, CAL, 2.0 DRILL BIT HTW ARTHREX, INC. DYNANITE® STAPLE DRILL BIT, CAL, 2.0 032006 00888867326200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown