BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERASP,4.0MM X 13CM

    MDR report key: 17343332 · Received July 18, 2023

    Report

    Report Number
    1220246-2023-07192
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 12, 2023
    Report Date
    February 25, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043619
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    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 MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400BC BONE CUTTER AND AR-8400PR POWERRASP DO NOT WORK. THE SAME PROBLEM CONTINUES 2 TIMES. THIS WAS DISCOVERED DURING A CASE, USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840058 POWERASP,4.0MM X 13CM MANUAL INSTR, GENERAL SURGICAL GFF ARTHREX, INC. POWERASP,4.0MM X 13CM 14938486 00888867043619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown