BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 19488076 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05313
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 19, 2023
    Report Date
    July 1, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR ON THE MOTOR.

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR.

    Description of Event or Problem · 0

    ON 04/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT ON (B)(6) 2023, AN AR-8330H SHAVER BROKE DURING THE CASE. IT BEGAN TO OVERHEAT THEN STOPPED WORKING. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327203 SHAVER HP, APSII, HAND CONTROL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL 00888867043237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown