BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, SYNERGY, HANDCONTROL

    MDR report key: 24833076 · Received April 9, 2026

    Report

    Report Number
    1220246-2026-02106
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867123991
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (SHP CABLE) THIS EVALUATION DETERMINED THAT THE CAUSE IS ATTRIBUTABLE TO THE NORMAL WEAR AND TEAR OF THE SHAVER HANDPIECE CABLE.

    Description of Event or Problem · 0

    ON 19-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8332H SHAVER HAD EXPOSED WIRES AT THE BASE. A CASE WAS INVOLVED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893207 SHAVER HP, SYNERGY, HANDCONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, SYNERGY, HANDCONTROL 15156501 00888867123991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown