BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APS II SHVR HANDP,FT-SWCH CNTRL

    MDR report key: 17974834 · Received October 20, 2023

    Report

    Report Number
    1220246-2023-08271
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 20, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043220
    PMA / PMN Number
    K932699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (SHP CABLE) THE EVALUATION CONFIRMED THE REPORTED EVENT, "IT WAS REPORTED THAT THE DEVICE HAS CUTS IN THE CABLE. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED." AND ATTRIBUTED TO NORMAL WEAR AND TEAR DUE TO THE AGE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAS CUTS IN THE CABLE. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933200 APS II SHVR HANDP,FT-SWCH CNTRL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. APS II SHVR HANDP,FT-SWCH CNTRL UNK 00888867043220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown