BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRFL DRL, 5.0MM CMPR FT

    MDR report key: 17514582 · Received August 11, 2023

    Report

    Report Number
    1220246-2023-07481
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 13, 2023
    Report Date
    December 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867263703
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE COMPLAINT ALLEGATION IS NOT CONFIRMED. THE COMPLAINT ALLEGATION OF BURNING IS UNCLEAR FROM THE IMAGE SUBMITTED FOR EVALUATION. 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 IS ATTRIBUTED TO MISUSE DUE TO PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8750-05 PROFILE DRILL WAS OVERHEATING AND BURNING BONE WITH USE. THIS OCCURRED DURING A DIAPHYSECTOMY OF PROXIMAL TIBIA PROCEDURE ON (B)(6) 2023. NO PIECE BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762253 PRFL DRL, 5.0MM CMPR FT DRILL BIT HTW ARTHREX, INC. PRFL DRL, 5.0MM CMPR FT 1392252 00888867263703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other