BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM

    MDR report key: 3243602 · Received July 23, 2013

    Report

    Report Number
    0009617544-2013-00279
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: CLEAR VISUAL DEFECT ON SCREW HEAD. THE HEAD OF THE POLY AXIAL SCREW IS INDENTED/FLATTENED INDICATING PREVIOUS USE AND RESTRICTING THE PASSAGE OF THE K-WIRE. FUNCTIONAL INSPECTION: VISUAL CONFIRMATION OF FAILURE/REUSE, NO FURTHER TESTS REQUIRED. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE DEVICE FAILURE WAS CONFIRMED UPON VISUAL INSPECTION OF THE SCREW HEAD/CANNULATION. THE DAMAGE ON THE DEVICE INDICATED PREVIOUS USE, WHICH SUBSEQUENTLY CAUSED THE IMPEDIMENT OF THE K-WIRE. THE FAILURE CAUSED A SURGICAL DELAY OF 5 MINUTES AND RESULTED IN NO OTHER ADVERSE CONSEQUENCES. THE IMPLANT IS SPECIFICALLY A SINGLE-USE DEVICE AND THIS IS CLEARLY INDICATED IN THE INSTRUCTIONS FOR USE. A NONCONFORMANCE HAS BEEN ISSUED TO ADDRESS THE ISSUE OF IMPLANT REUSE.

    Description of Event or Problem · 1

    THE CASE WAS UTILIZING MANTIS PERCUTANEOUS SCREWS FOR SPINAL FIXATION. DURING THE LOADING PROCESS OF ONE OF THE CANNULATED SCREWS IT WAS FOUND THAT THE K-WIRE WAS NOT ABLE TO BE INSERTED ALL THE WAY THROUGH THE CANNULATION. THE SCREW WAS REMOVED FROM THE SCREWDRIVER AND REPLACED WITH ANOTHER SCREW.

    Description of Event or Problem · 1

    THE CASE WAS UTILIZING MANTIS PERCUTANEOUS SCREWS FOR SPINAL FIXATION. DURING THE LOADING PROCESS OF ONE OF THE CANNULATED SCREWS IT WAS FOUND THAT THE K-WIRE WAS NOT ABLE TO BE INSERTED ALL THE WAY THROUGH THE CANNULATION. THE SCREW WAS REMOVED FROM THE SCREWDRIVER AND REPLACED WITH ANOTHER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343105 MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM IMPLANT MNH STRYKER SPINE-FRANCE 07A570

    Patients

    Seq Age Sex Outcome Treatment
    1