BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, SYNERGY, HANDCONTROL

    MDR report key: 24895493 · Received April 16, 2026

    Report

    Report Number
    1220246-2026-02253
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867123991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (USE ERROR) THIS EVALUATION DETERMINED THAT THE REPORTED EVENT OCCURRED DUE TO MISUSE RESULTING IN DAMAGED OF THE SHP CABLE CORD.

    Description of Event or Problem · 0

    ON 27-MAR-2026, A FACILITIES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8332H SHAVER HANDPIECE HAS A CUT IN THE CORD. THIS ISSUE WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554577 SHAVER HP, SYNERGY, HANDCONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, SYNERGY, HANDCONTROL 15310115 00888867123991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown