BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40

    MDR report key: 11284922 · Received February 5, 2021

    Report

    Report Number
    3005180920-2021-00087
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OUR
    UDI-DI
    07630030881084
    PMA / PMN Number
    K171595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED ON 17-FEB-2021 AND ANALYZED ON 23-FEB-2021. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. VISUAL INSPECTION PERFORMED ON THE 23RD FEBRUARY 2021. DURING A REVISION SURGERY, ACCORDING TO THE COMPLAINT INFORMATION, THE SI-JOINT SCREW WAS EXTRACTED VERY EASILY, BUT THE WASHER REMAINED IN PLACE. MUST SI-JOINT SCREWS AND WASHERS ARE DESIGNED TO BE INTRAOPERATIVELY ASSEMBLED BY MEANS OF A DEDICATED INSTRUMENT BEFORE THEIR INSERTION INTO THE BONE; ONCE ASSEMBLED, IMPLANT DESIGNS (INTERFERENCE BETWEEN SCREW HEAD EXTERNAL SURFACE AND WASHER INNER CAVITY) ENSURE THAT THE WASHER CAN FREELY ROTATE AROUND THE SCREW HEAD, BUT THEIR DISASSEMBLING IS AVOIDED. THEIR DISASSEMBLING REQUIRES AN HIGH AXIAL FORCE THAT CANNOT BE MANUALLY APPLIED. THE RECEIVED IMPLANTS HAVE BEEN INSPECTED AND THEIR COUPLING SURFACES ARE INSIDE DRAWING TOLERANCES (SCREW Ø10.44MM - WASHER 10.34MM - INTERFERENCE OF 0.10MM). THEY HAVE BEEN SUCCESSFULLY AND EASILY ASSEMBLED WITH THE DEDICATED INSTRUMENT (03.65.10.0035), AND IT WAS POSSIBLE TO DISASSEMBLE THEM ONLY USING AN HAMMER IN MORE THAN ONE ATTEMPTS. FOR THESE REASONS, THE POTENTIAL ROOT CAUSE COULD BE THE NOT PROPER AND COMPLETE SCREW-WASHER ASSEMBLING DURING THE PRIMARY SURGERY, THAT LED TO THE UNEXPECTED DISASSEMBLING DURING THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 FEBRUARY 2021: LOT 1923300: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 01 FEBRUARY 2021: SACRO-ILIAC SCREW SYSTEM 03.65.913 FAVORED ANGLE WASHER Ø17MM, TI (K171595) LOT. 1924155 LOT 1924155: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2020. EXPIRATION DATE: 2025-03-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 1 MONTH AFTER PRIMARY SURGERY FOR SCREW MALPOSITIONING. THE SCREW WAS IMPLANTED 2MM TOO DEEP INTO THE BONE DURING THE PRIMARY LEAD TO CONTACT WITH NERVE ROOT L5. DURING REVISION, THE SCREW CAME OUT VERY EASILY, BUT THE WASHER NEEDED SEVERAL EXTRACTION ATTEMPTS TO BE REVISED. FINALLY REMOVED USING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181476 SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40 SACRO ILIAC SCREWS OUR MEDACTA INTERNATIONAL SA 03.65.704 1923300 07630030881084

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention