BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, STRAIGHT, 13MM DIAM. 2.0 MM

    MDR report key: 20685244 · Received November 14, 2024

    Report

    Report Number
    1220246-2024-08528
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    April 8, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867028630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE REPORTED EVENT IS CONFIRMED. THE BURR DRILL WAS BROKEN INSIDE THE BURR ATTACHMENT, MOST LIKELY DUE TO MISUSE. THIS COULD HAVE BEEN CAUSED BY HITTING THE DEVICE WITH ANOTHER OBJECT, PRYING OR LEVERAGING, OR APPLYING EXCESSIVE BENDING FORCES DURING USE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MINIMALINVASIVE MICA SURGERY THE ATTACHMENT BROKE OFF. THE END REMAINED ATTACHED INSIDE THE ADAPTOR. THE PART BROKE OFF OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 DW (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER THAT THE INITIAL REPORTED EVENT WAS INCORRECT. IT WAS CONFIRMED THAT THE ATTACHMENT HAD NO ISSUE BUT AN ARTHREX DRILL BIT HAS BROKEN OFF AND A PART REMAINED STUCK INSIDE THE ATTACHMENT. THE CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER DETAILS WHICH DRILL BIT HAS BROKEN OFF HOWEVER DURING THE EVALUATION A PICTURE OF THE END OF DRILL BIT HAS SHOWN THAT IT HAS A DIAMETER OF 2MM AND THE CUSTOMER ONLY PURCHASED ONE AR-300-B001 WITH THE BATCH 037417 WHICH FITS THIS SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204895 BURR, STRAIGHT, 13MM DIAM. 2.0 MM BURR,SURGICAL LXH ARTHREX, INC. BURR, STRAIGHT, 13MM DIAM. 2.0 MM 037417 00888867028630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown