BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING GUIDE,LT, NARROW VOLAR DRP

    MDR report key: 22336283 · Received June 26, 2025

    Report

    Report Number
    1220246-2025-02650
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    May 1, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867130043
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WEAR AND TEAR INCURRED FROM REPEATED USAGE/REPROCESSING.

    Description of Event or Problem · 0

    ON 06/04/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8916-04 AIMING GUIDE DOES NOT SETTLE PROPERLY AND ROTATES, CAUSING THE PLATE HOLE AND AIMING GUIDE HOLE TO BECOME MISALIGNED. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538836 AIMING GUIDE,LT, NARROW VOLAR DRP MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. AIMING GUIDE,LT, NARROW VOLAR DRP UNK 00888867130043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown