BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER HP, APSII, HAND CONTROL

    MDR report key: 19262245 · Received May 7, 2024

    Report

    Report Number
    1220246-2024-02910
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    March 22, 2022
    Report Date
    May 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043237
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(6) 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE IS GETTING HOT. THE REPORTED EVENT WAS CONFIRMED. THE SERVICE EVALUATION REVEALED A SHORT CIRCUIT IN THE MOTOR. FURTHERMORE, BOTH CABLE AND HOUSING ARE WORN OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS GETTING HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE (B)(6) 2022 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING THE SURGERY. ACCORDING TO THE CUSTOMER NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE (B)(6) 2022 IT WAS FURTHER CONFIRMED THAT THE SURGERY TOOK PLACE ON THE (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454390 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