BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTAR SPINE MUST SCREWDRIVER - SHORT

    MDR report key: 18543116 · Received January 19, 2024

    Report

    Report Number
    3005180920-2023-01111
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 28, 2023
    Report Date
    February 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OLO
    UDI-DI
    07630345728968
    PMA / PMN Number
    K210859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JANUARY 2024. LOT 2252515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, FOUR OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&SPINE PROJECT MANAGER ON (B)(6) 2024: THE SCREWDRIVER'S TIP IS BROKEN MOST PROBABLY BECAUSE THE BONE TAPPING WAS NOT PERFORMED FOR THE ENTIRE DEPTH (85MM) NECESSARY TO INSERT THE ENH POLY-AXIAL PEDICLE SCREW - CANNULATED 8X85MM. CORRECTIONS. H1 IS MALFUNCTION. H5 IS NO.

    Description of Event or Problem · 0

    DURING NEXTAR SURGERY, THE TIP OF SCREWDRIVER BROKE DURING PEDICLE SCREW 8.0X85MM INSERTION. TAPPING 8.0 WAS PERFORMED INITIALLY. IT TOOK TIME TO RETRIEVE THE BROKEN PIECE FROM THE PEDICLE SCREW HEAD, BUT FINALLY PEDICLE SCREW WAS ABLE TO RETRIEVE. ADDITIONAL TAPPING PERFORMED AND THE SURGERY FINISHED WITH PEDICLE SCREW 8.0X75MM. BACKUP SCREWDRIVER (SAME LOT) SUCCESSFULLY USED. DELAY TIME 40 MIN TO RETRIEVE THE BROKEN PART OF THE SCREWDRIVER AND REVISE THE PEDICLE SCREW. TOTAL SURGERY TIME ABOUT 4 HOURS AND 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400220 NEXTAR SPINE MUST SCREWDRIVER - SHORT INSTRUMENT FOR SPINE SURGERIES OLO MEDACTA INTERNATIONAL SA 2252515 07630345728968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other