BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 19163847 · Received April 23, 2024

    Report

    Report Number
    1220246-2024-02191
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (SHP CABLE) THE EVALUATION CONFIRMED THE REPORTED EVENT, "ON 03/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT ANAR-8330H SHAVER HANDPIECE HAD A CUT IN THE CORD. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM." AND ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 0

    ON 03/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT ANAR-8330H SHAVER HANDPIECE HAD A CUT IN THE CORD. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947836 SHAVER HP, APSII, HAND CONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 14939886 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown