BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 9.5MM

    MDR report key: 8635726 · Received May 23, 2019

    Report

    Report Number
    1219602-2019-00593
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 2, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER REVIEW OF THIS EVENT PERFORMED ON (B)(6) 2019, HAS IDENTIFIED THAT THE COMPLAINT DESCRIPTION MENTIONS A SITUATION WHERE THE DRILLER WAS CLOGGED WITH BONE DEBRIS AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE WITH NO PATIENT HARM. THIS EVENT WAS RE-EVALUATED FOR MDR REPORTING. THE REASSESSMENT DETERMINED THAT, BASED ON THE EVENT INFORMATION, THE ISSUE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THIS REPORT WAS MADE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAD NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION OPERATION IN OR, TRUNAV DRILL ACTUATOR FAILED PROXIMALLY WHEN THE SURGEON TRIED TO ACTUATE THE CUTTER. THIS FAILURE OCCURRED DUE TO BUILDUP OF BONE DEBRIS AROUND THE CUTTER DURING ANTEGRADE DRILLING OF FEMORAL TUNNEL. THE SURGEON TRIED TO CLEAR THE BONE DEBRIS BEING STOCKED AROUND THE CUTTER BY FLOSSING ACTION USING TRUNAV GUIDEWIRE, BUT IT DID NOT WORK AND CONSEQUENTLY THE ACTUATOR FAILED TO DEPLOY THE CUTTER. A SECOND TRUNAV DRILL WAS USED TO FINISH RETROGRADE DRILLING AND THE OPERATION WAS COMPLETED SUCCESSFULLY. NO DELAY OR PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428233 RETROGRADE DRL 9.5MM BIT, SURGICAL GFG SMITH & NEPHEW, INC. 4726281

    Patients

    Seq Age Sex Outcome Treatment
    1