BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 18551979 · Received January 22, 2024

    Report

    Report Number
    1220246-2024-00426
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    December 28, 2023
    Report Date
    March 25, 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

    ADDITIONAL INFORMATION: D9, G3, H6 (SHP CABLE) THE EVALUATION CONFIRMED THE REPORTED EVENT, "ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06441828 THAT AN AR-8330H SHAVER HAND PIECE CORD HAS CUT AND THE WIRING IS EXPOSED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM." AND ATTRIBUTED IT TO NORMAL WEAR AND TEAR, DUE TO THE AGE OF THE SHP CABLE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8330H SHAVER HAND PIECE CORD HAS CUT AND THE WIRING IS EXPOSED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405668 SHAVER HP, APSII, HAND CONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 10084551 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown