BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERASP,4.0MM X 13CM

    MDR report key: 17464679 · Received August 4, 2023

    Report

    Report Number
    1220246-2023-07430
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    June 29, 2023
    Report Date
    October 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043619
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE DEVICE REVEALED THE ATTACHMENT HUB WAS BENT. SEE PHOTO 1. IN ADDITION, THERE IS CORROSION VISIBLE ON THE SHAFT OF THE DEVICE. SEE PHOTO 2. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE ATTACHMENT DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE POWERASP MELTED AND CAME APART IN THE HAND PIECE. THE SAME THING HAPPENED WITH SECOND ONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Description of Event or Problem · 0

    UPDATE SWIT 18-AUG-2023: ACCORDING TO THE SURGEON, HE WAS DOING NOTHING OUT OF THE ORDINARY BUT THAT TOWARDS THE BACK OF THE JOINT THE RASP STOPPED WORKING AND WHEN HE TOOK IT OUT, THE END HAD BEEN MELTED. HE DIDN¿T KNOW WHAT HAPPENED AS HE USED THE SAME WAY AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960828 POWERASP,4.0MM X 13CM MANUAL INSTR, GENERAL SURGICAL GFF ARTHREX, INC. POWERASP,4.0MM X 13CM 13248048 00888867043619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown