BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS REDUX TORQUE WRENCH

    MDR report key: 2241061 · Received August 17, 2011

    Report

    Report Number
    9617544-2011-00285
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MFG RECORD REV, RISK ASSESSMENT, VISUAL INSPECTION AND AN INSTRUMENT FROM SAME BATCH PREVIOUSLY UNDERWENT FRACTOGRAPHIC EVAL. RESULTS: COMPLAINT HISTORY ANALYSIS. THREE COMPLAINTS RELATED TO THIS CASE. MFG RECORD REV. NO DEVIATIONS REPORTED, 2ND COMPLAINT ON THIS BATCH FOR SAME FAILURE. RISK ASSESSMENT. NO ADVERSE CONSEQUENCES IN THIS CASE. VISUAL INSPECTION. TIP CONFIRMED BROKEN, TIP RETURNED. SAME BATCH EVAL. PREVIOUS FAILURE WAS PROVOKED BY STATIC STRESSES. THE METAL HAD ELEVATED HARDNESS RESULTS, THOUGH NO CORRELATION WAS ESTABLISHED WITH THE RUPTURE. CONCLUSION: A CAPA WAS INITIATED TO IDENTIFY THE ROOT CAUSE AND A DESIGN AND MFG CHANGE AND WERE IMPLEMENTED ON (B)(6) 2011. POSSIBLE CAUSES FOR TIP BREAKAGE INCLUDE THE TIP NOT BEING FULLY INSERTED, OVER-TIGHTENING AND ANGULATION DURING TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. (B)(6) WAS FINAL TIGHTENING ON PT WITH MANTIS REDUX TORQUE WRENCH. DR. (B)(6) WAS FINAL TIGHTENING ONE SCREW, AT AN ANGLE, WHEN THE TIP BROKE OFF FROM THE TORQUE WRENCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS REDUX TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 098400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK