BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 5.5 X 45 MM

    MDR report key: 3232088 · Received July 17, 2013

    Report

    Report Number
    0009617544-2013-00268
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: THE DEVICE FAILURE IS CONFIRMED UPON VISUAL INSPECTION. THE TABS ON ONE SIDE OF THE SCREW-HEAD THAT SERVE AS A MECHANICAL CONNECTION TO THE BLADES ARE BROKEN OFF. THERE IS SCRATCHING AND OTHER SIGNS OF NORMAL WEAR ON THE OUTSIDE OF THE SCREW-HEAD. FUNCTIONAL INSPECTION: NOT APPLICABLE. THE DEVICE FUNCTION IS CLEARLY IMPAIRED BASED ON THE VISUAL INSPECTION. DEVICE HISTORY REVIEW: NO NON CONFORMITIES OR DEVIATIONS LINKED WITH REPORTED EVENT WERE NOTED DURING MANUFACTURING PROCESS. CONCLUSION: THE TAB BREAKAGE ON THE SCREW-HEAD WAS CONFIRMED UPON VISUAL INSPECTION. ALL THREE SCREWS WITHIN THIS PI FAMILY WERE CONFIRMED TO HAVE FAILED UPON VISUAL INSPECTION. FURTHERMORE, THE SCREW TABS ONLY BROKE ON ONE SIDE OF THE IMPLANT. BASED ON THE EXTENSIVE HISTORY OF THIS FAILURE, CIRCUMSTANCES OF USE (SPECIFICALLY THE USE OF THE PERSUADER AT THE TIME OF THE FAILURE), AND THE ONE-SIDED PATTERN OF BREAKAGE, IT IS HIGHLY LIKELY THAT THE FAILURE IS A RESULT OF OFFSET PERSUADER REDUCTION RESULTING IN CANTILEVER FORCES ON A SINGLE SIDE OF THE SCREW-HEAD. THE REPORTED FAILURE CAUSED A ONE HOUR DELAY IN SURGERY FOR EACH SCREW (3 COMPLAINTS FOR THIS PI FAMILY), A TOTAL OF 3 HOURS AND IT IS UNKNOWN WHETHER THE BROKEN FRAGMENTS REMAIN IN THE PATIENT. IN THE PAST THIS HAS BEEN A RECURRENT ISSUE AND A CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ISSUE. THE MANTIS SURGICAL TECHNIQUE HAS BEEN UPDATED TO DRAW DELIBERATE ATTENTION TO THE PROPER USE OF THE PERSUADER TO PREVENT TAB BREAKAGE DUE TO EXCESS FORCE OR OFFSET ALIGNMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "3 MANTIS SCREWS HAVE BROKEN DURING THE SURGERY. THE FINS OF THE SCREWS ESPECIALLY. IT CONCERNED A MOUNTING FROM A SCREW T11 TO L3 WITH BRACING ON L1. THE FINS STAYED ATTACHED TO THE PERSUADER AND THE SURGEON REMOVED THE BROKEN STEM AND REPLACE THE 3 SCREWS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "3 MANTIS SCREWS HAS BROKEN DURING THE SURGERY. THE FINS OF THE SCREWS ESPECIALLY. IT CONCERNED A MOUNTING FROM A SCREW T11 TO L3 WITH BRACING ON L1. THE FINS STAYED ATTACHED TO THE PERSUADER AND THE SURGEON REMOVED THE BROKEN STEM AND REPLACED THE 3 SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332496 MANTIS CANNULATED POLYAXIAL SCREW 5.5 X 45 MM IMPLANT MNH STRYKER SPINE-FRANCE 135387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention