BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 7.5MM

    MDR report key: 6224737 · Received January 5, 2017

    Report

    Report Number
    1643264-2017-00014
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 12, 2016
    Report Date
    March 27, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DRILL HEAD HAS SPLIT IN TWO PIECES AND HAS COME FREE FROM THE DRILL SHAFT. THE BREAK IS A CLEAN SHEAR. THE ACTUATOR WIRE IS SPIRALED IN THE FORWARD DRILLING POSITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LIGAMENTOPLASTY ACL PROCEDURE, THE DEVICE BROKE INTO 3 PARTS INSIDE THE KNEE OF THE PATIENT. NO REPORTED PATIENT INJURIES. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9053 RETROGRADE DRL 7.5MM BIT, SURGICAL GFG SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR