BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER

    MDR report key: 2772277 · Received October 2, 2012

    Report

    Report Number
    9617544-2012-00420
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW AND RISK ASSESSMENT. RESULTS: THERE HAVE BEEN 34 PREVIOUS COMPLAINTS INVOLVING 36 UNITS SINCE 2004. THE TIP OF THE SCREWDRIVER WAS CONFIRMED TO BE BROKEN, THE BROKEN TIP WAS NOT RETURNED. THE INSTRUMENT WAS INSERTED INTO A REFLEX HYBRID SCREW AND WAS DEEMED TO BE FUNCTIONAL. THE DEVICE HISTORY FOR THIS DEVICE'S BATCH WAS REVIEWED AND NO RELEVANT DEVIATIONS WERE REPORTED. IN THIS CASE THERE WAS NO PATIENT INVOLVEMENT. A MEDICAL OPINION WAS REQUESTED FOR A PREVIOUS COMPLAINT; IT STATED THAT GIVEN THE SMALL SIZE OF THE FRAGMENT IT WOULD NOT MIGRATE TO ANY DEGREE AND THERE IS VERY LITTLE RISK OF ANY HARM TO A PATIENT, HAD THE BREAKAGE OCCURRED DURING SURGERY. CONCLUSION: THE FAILURE CAN OCCUR IF THE INSTRUMENT IS NOT CORRECTLY INSERTED INTO THE SCREW-HEAD DURING FINAL TIGHTENING OR SCREW REMOVAL AND PIVOTING OR CANTILEVER FORCES ARE APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WAS GOING THROUGH OUR REFLEX HYBRID SET AND NOTICED THAT THE VERY TIP OF THE HYBRID FINAL TIGHTENER WAS MISSING. THERE SHOULD BE A SMALL LITTLE NIPPLE ON THE END OF THE DRIVER AND IT IS NOT THERE. NOT SURE WHEN, HOW, OR WHERE IT GOT BROKEN OFF. JUST NOTICED IT WHEN I WAS GOING THROUGH THE SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER INSTRUMENT HXX STRYKER SPINE BORDEAUX NA 104246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA