BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 20135477 · Received September 4, 2024

    Report

    Report Number
    1220246-2024-07351
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (SHP CABLE) THE EVALUATION CONFIRMED THE REPORTED EVENT "AR-8330H SHAVER HANDPIECE HAD A RIP IN THE CORD." AND ATTRIBUTED IT TO USE ERROR.

    Description of Event or Problem · 0

    ON 08/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HANDPIECE HAD A RIP IN THE CORD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967178 SHAVER HP, APSII, HAND CONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 14961533 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown