BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT

    MDR report key: 7142976 · Received December 22, 2017

    Report

    Report Number
    3005180920-2017-00775
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 24, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION BASED ON THE PICTURE OF THE EXPLANTED SCREW BY R&D PROJECT MANAGER ON (B)(6) 2017: THE SCREW SHEARED OFF AT THE INTERFERENCE WITH THE TIBIAL BASEPLATE. THE PIECE WAS BROKEN IN 2 PARTS IN CORRESPONDENCE OF THE BEGINNING OF THE THREADED PART OF THE SCREW. ONE BROKEN PART OF THE SCREW REMAINED INTO THE BASEPLATE WITH NO POSSIBILITY TO BE REMOVED THE EVENT WAS PROBABLY CAUSED BY AN EXCESSIVE TIGHTENING TORQUE APPLIED ON THE SCREW DURING FIXATION. THE TORQUE LIMITER SCREWDRIVER WAS NOT USED DURING PRIMARY SURGERY. USING A SCREWDRIVER PROVIDED WITH A TORQUE LIMITATION (REF 02.07.10.4577; TORQUE LIMITER SCREWDRIVER 3.5 NM) WOULD PREVENT TO EXCEED THE BREAKING POINT. THIS TYPE OF SCREWDRIVER IS ALREADY AVAILABLE AND ITS USAGE IS CURRENTLY MANDATORY. THE SCREW WAS REMOVED ARTHROSCOPICALLY. IT MEANS THAT THE SURGEON CONSIDERED THE ARTICULAR SURFACE OF THE FEMORAL COMPONENT AND THE TIBIA INSERT NOT DAMAGED BY THE LOOSENED SCREW. BATCH REVIEW PERFORMED ON 22 DECEMBER 2017: LOT 153772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2015; EXPIRATION DATE: 2020-10-27. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ADDITIONAL SURGERY NECESSARY DUE TO BREAKAGE OF THE SCREW. NO TORQUE LIMITER HAS BEEN USED IN PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922607 GMK SPHERE TIBIAL INSERT TIBIAL PE INSERT JWH MEDACTA INTERNATIONAL SA 153772 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention