BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 8MM

    MDR report key: 6214483 · Received December 29, 2016

    Report

    Report Number
    1643264-2016-00314
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 16, 2016
    Report Date
    December 19, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ASSESSMENT OF THE DRILL CONFIRMED THE ACTUATOR WIRE HAS DISENGAGED FROM THE CUTTER BY UNCOILING AT THE LOOP. THIS CONDITION INDICATES THAT THE WINDOW OF THE DISTAL SHAFT WAS NOT FULLY INSIDE THE JOINT SPACE AND DID NOT ALLOW FOR THE DEPLOYMENT OF THE CUTTER. WHEN THE CUTTER CANNOT ROTATE, THE ACTUATOR WIRE WILL EITHER DEFORM OR DISENGAGE FROM THE CUTTER. ADDITIONALLY, WHEN VIEWING THE VIDEO THAT WAS PROVIDED, IT WAS OBSERVED THAT ENTIRE DISTAL SHAFT WINDOW WAS NOT FULLY INSIDE THE JOINT SPACE WHEN THE ATTEMPT TO ACTUATE THE CUTTER OCCURRED. THE DEVICE WAS THEN ROTATED AND THE DISENGAGEMENT OF THE ACTUATION WIRE COULD BE SEEN AS THE SURGEON CONTINUED TO ATTEMPT TO ACTUATE AND DEPLOY THE CUTTER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USER ERROR. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETROGRADE DRILL BIT BROKE IN THE PATIENT DURING A LIGAMENTOPLASTY PROCEDURE. DEVICE FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT. A DELAY OF 30-60 MINUTES WAS REPORTED. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862331 RETROGRADE DRL 8MM BIT, SURGICAL GFG SMITH & NEPHEW, INC. F92147

    Patients

    Seq Age Sex Outcome Treatment
    1