BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 12953736 · Received December 7, 2021

    Report

    Report Number
    1220246-2021-04057
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 17, 2021
    Report Date
    February 4, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE OPERATED TO SPECIFICATION, THE INVESTIGATION OF THE REPORTED EVENT OF 'AR-8330H SHP OVERHEATED' WILL BE CONSIDERED CONFIRMED BASED ON THE SURGEON'S COMMENTS AND ATTRIBUTED TO MISHANDLING.

    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

    IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT AN AR-8330H SHP OVERHEATED. THIS WAS DISCOVERED DURING A CASE, SURGEON AND PATIENT WERE BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855495 SHAVER HP, APSII, HAND CONTROL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 10148162 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other