BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 8.5MM

    MDR report key: 6233983 · Received January 9, 2017

    Report

    Report Number
    1643264-2017-00018
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 13, 2016
    Report Date
    March 23, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION IS NOT POSSIBLE, AS THE DEVICE WILL NOT BE RETURNED, HOWEVER A PHOTOGRAPH WAS PROVIDED. THE PHOTO SHOWS WHAT APPEARS TO BE A BROKEN RETROGRADE DRILL WITHIN THE BONE TUNNEL. PER THE CLINICAL INFORMATION PROVIDED: SURGEON HAD TROUBLE POSITIONING THE DEVICE OUTSIDE THE FEMORAL TUNNEL DURING AN ACLR DUE TO THE CLOSE PROXIMITY TO THE PCL. SURGEON DEPLOYED THE CUTTING BLADE WITHOUT POSITIONING THE DEVICE FAR ENOUGH OUT OF THE TUNNEL CAUSING THE ACTUATION WIRE TO LOSE CONTROL OF CUTTING BLADE. DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT. SURGEON OPTED TO USE A DIFFERENT TECHNIQUE WITH OTHER PRODUCTS TO FINISH THE CASE. TO ENSURE PROPER CUTTING BLADE DEPLOYMENT, POSITION THE DRILL HEAD SO THAT IT HAS SUFFICIENT CLEARANCE AND THE ENTIRE DRILL HEAD WINDOW IS VISIBLE BEYOND THE BONE TUNNEL APERTURE (APPROXIMATELY 0.6 INCHES [15 MM])¿. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    UNSPECIFIED FUNCTIONAL FAILURE IT WAS REPORTED THE RETROGRADE DRL 8.5MM CUTTER BROKE. THIS OCCURRED DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE OF 0-30MIN. NO PATIENT INJURIES WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18252 RETROGRADE DRL 8.5MM BIT, SURGICAL GFG SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1