BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM

    MDR report key: 19185872 · Received April 25, 2024

    Report

    Report Number
    1220246-2024-02416
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    February 3, 2021
    Report Date
    April 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867326101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. COMPLAINT CONFIRMED, THE ID OF ONE OF THE GUIDES IS SEVERELY DAMAGED. THE UNDAMAGED IDS WERE FOUND TO MEET SPECIFICATIONS . A LIKELY CAUSE OF THE EVENT IS PRYING/LEVERAGING THE MATING DRILL BIT DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DRILLING FROM THE GUIDE SLEEVE PART, IT DID NOT PROCEED SMOOTHLY. THE CONTACT AREA AT THE BASE OF THE DRILL HAD A SCORCHED MARK. A NEW GUIDE AND DRILL WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162169 DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM UNK 00888867326101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown