BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM

    MDR report key: 17514673 · Received August 11, 2023

    Report

    Report Number
    1220246-2023-07485
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 13, 2023
    Report Date
    February 5, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043848
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICES DUE TO SIDE-LOADING THE DEVICES DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE DETACHED FROM THE ATTACHMENT. THE DETACHED BLADE COULD BE COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595359 BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM BURR,SURGICAL GFF ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM 15045291 00888867043848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown