BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.70MM DRILL FOR FIBERTAK

    MDR report key: 20217556 · Received September 13, 2024

    Report

    Report Number
    1220246-2024-07613
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 21, 2024
    Report Date
    January 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867101920
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-3600D-3 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DRILL SHAFT IS BROKEN/DAMAGED. THE METHOD USED TO PREPARE THE BONE, AS WELL AS THE BONE QUALITY ENCOUNTERED DURING THE PROCEDURE, WERE NOT PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    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 AN INSTABILITY SURGERY OF THE SHOULDER THE DRILL BROKE OFF. IT WAS NOT NOTED AND THE PART REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE DW 04-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE LOT NUMBER OF THE DEVICE WAS FOUND TO BE 022223. IT WAS FURTHER REPORTED THAT NO ADDITIONAL SURGERY AS IT WAS CONFIRMED ON THE CT THAT THE PART IS EMBEDDED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667030 1.70MM DRILL FOR FIBERTAK DRILL BIT HTW ARTHREX, INC. 1.70MM DRILL FOR FIBERTAK 022223 00888867101920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown