BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/23MM

    MDR report key: 6640056 · Received June 14, 2017

    Report

    Report Number
    3005180920-2017-00304
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 16, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MAY 2017. LOT 163646: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JUNE 2016. EXPIRATION DATE: 2021-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. ALL PIECES OF THIS LOT HAVE BEEN RECALL FROM THE MARKET. ON 14 JUNE 2017 THE CLEANING AND PACKAGING MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS (THE SECOND OPENED LINER PLUS THE POST FIXATION SCREW, AND THE WRONG POST FIXATION SCREW FOUND IN THE FIRST OPENED LINER), AND COMMENTED AS FOLLOWS: THE HINGE INLAY LOCKING SCREW WAS MISSING. THERE WERE TWO (2) HINGE POST FIXATION SCREWS, WHILE THE REQUIREMENT IS TO HAVE 1 INLAY LOCKING SCREW AND 1 POST FIXATION SCREW. THE PRIMARY ROOT CAUSE IS THE LACK OF VISUALLY EVIDENCE AND DISTINGUISHING IDENTIFICATION OF VERY SIMILAR, BUT DIFFERENT PARTS, BEING APPLIED WITHIN THE SAME FINAL PACKAGING ASSEMBLY. ADDITIONALLY, A LACK OF AN ADDITIONAL SUBSEQUENT VERIFICATION STEP CONTRIBUTED TO THE LACK OF DETECTION. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED IN ORDER TO AVOID SIMILAR CASES IN THE FUTURE. THE LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    THE HINGE INLAY LOCKING SCREW WAS MISSING. TWO HINGE POST FIXATION SCREWS WERE FOUND IN THE PACKAGING. A SECOND INSERT HAD TO BE USED IN ORDER TO HAVE THE CORRECT LOCKING SCREW. THE SURGERY WAS THUS COMPLETED WITH THE FIRST LINER AND THE LOCKING SCREW OF THE SECOND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420577 GMK-HINGE FIXED TIBIAL INSERT SIZE 2/23MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 163646

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other