BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 35 MM

    MDR report key: 2867844 · Received December 7, 2012

    Report

    Report Number
    9617544-2012-00552
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY ANALYSIS, MANUFACTURING RECORD REVIEW, DEVICE INSPECTION AND RISK ASSESSMENT. RESULTS: COMPLAINT HISTORY ANALYSIS, THERE HAVE BEEN (B)(4) TOTAL COMPLAINTS INVOLVING (B)(4) UNITS RELATING TO BROKEN TULIP TABS DURING SURGERY. PREVIOUS COMPLAINTS WERE METALLURGICALLY ANALYZED AND NO ISSUES WERE FOUND. THE PREVIOUS COMPLAINTS WERE FOUND TO BE THE RESULT OF CANTILEVER FORCES BEING APPLIED TO THE BLADES. MANUFACTURING RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE TAB BREAKAGE WERE REPORTED DURING THE MANUFACTURING OF EITHER BATCH 120326 OR BATCH 125311. VISUAL INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS UNAVAILABLE. RISK ASSESSMENT: IN THAT CASE THE SURGEON REMOVED THE FRAGMENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCLUSION: DUE TO THE RECURRENCE OF COMPLAINT (B)(4) WAS INITIATED. THE CAPA ROOT CAUSE ANALYSIS CONCLUDED THAT THE BREAKAGE OF THE TULIP TABS IS NOT ATTRIBUTABLE TO DESIGN OR MANUFACTURING, BUT TO ACCIDENTAL OFFSET DURING USE. SURGICAL TECHNIQUE HAS BEEN UPDATED TO INCLUDE A WARNING THAT THE MANTIS PERSUADER IS NOT INTENDED TO BE USED OFFSET WHILE REDUCING THE ROD INTO THE TULIP HEAD.

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY ANALYSIS, MANUFACTURING RECORD REVIEW, DEVICE INSPECTION AND RISK ASSESSMENT. RESULTS: COMPLAINT HISTORY ANALYSIS, THERE HAVE BEEN (B)(4) TOTAL COMPLAINTS INVOLVING (B)(4) UNITS RELATING TO BROKEN TULIP TABS DURING SURGERY. PREVIOUS COMPLAINTS WERE METALLURGICALLY ANALYZED AND NO ISSUES WERE FOUND. THE PREVIOUS COMPLAINTS WERE FOUND TO BE THE RESULT OF CANTILEVER FORCES BEING APPLIED TO THE BLADES. MANUFACTURING RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE TAB BREAKAGE WERE REPORTED DURING THE MANUFACTURING OF EITHER BATCH 120326 OR BATCH 125311. VISUAL INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS UNAVAILABLE. RISK ASSESSMENT: IN THAT CASE THE SURGEON REMOVED THE FRAGMENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCLUSION: DUE TO THE RECURRENCE OF COMPLAINT (B)(4) WAS INITIATED. THE CAPA ROOT CAUSE ANALYSIS CONCLUDED THAT THE BREAKAGE OF THE TULIP TABS IS NOT ATTRIBUTABLE TO DESIGN OR MANUFACTURING, BUT TO ACCIDENTAL OFFSET DURING USE. SURGICAL TECHNIQUE HAS BEEN UPDATED TO INCLUDE A WARNING THAT THE MANTIS PERSUADER IS NOT INTENDED TO BE USED OFFSET WHILE REDUCING THE ROD INTO THE TULIP HEAD.

    Description of Event or Problem · 1

    DURING MANTIS SURGERY, WHEN THE SURGEON USED THE PERSUADER AND DID THE PUSH OF THE ROD INTO THE SCREW HEAD, THE HEAD (TAB) OF THE SCREW BROKE. THE SURGEON REMOVED THE FRAGMENT AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 35 MM IMPLANT MNH STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR