BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPCUTTER II, SHORT 9.5MM

    MDR report key: 19352211 · Received May 20, 2024

    Report

    Report Number
    1220246-2024-03523
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    July 11, 2022
    Report Date
    May 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867004443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    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. VISUAL INSPECTION UNREMARKABLE. FUNCTIONAL TESTING FOUND THAT THE DEVICE WAS STUCK IN THE OPEN POSITION. COMPLAINT WAS CONFIRMED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE DID NOT DETACH AND REMAINED IN OPEN POSITION IN MILLING MODE. ACCORDING TO THE SURGEON 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 21-JUL-2022. IT WAS CONFIRMED THAT THE ERROR OCCURRED OUTSIDE OF THE PATIENT. UPDATE AVOE 05-AUG-2022. IT WAS FURTHER CONFIRMED THAT THE ERROR OCCURRED PRIOR TO USE OF THE DEVICE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542169 FLIPCUTTER II, SHORT 9.5MM MANUAL INSTR, GENERAL SURGICAL HWE ARTHREX, INC. FLIPCUTTER II, SHORT 9.5MM 1344117854 00888867004443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown