BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 17783755 · Received September 20, 2023

    Report

    Report Number
    1220246-2023-07968
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 28, 2023
    Report Date
    April 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (NO PROBLEM FOUND) THE EVALUATION DID NOT REVEAL ANY ISSUES RELEVANT TO THE REPORTED EVENT, "ON 08/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER BURR CONTINUES SPINNING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM."

    Description of Event or Problem · 0

    ON 08/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER BURR CONTINUES SPINNING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84712 SHAVER HP, APSII, HAND CONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 10021944 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown