BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER

    MDR report key: 2772276 · Received October 2, 2012

    Report

    Report Number
    9617544-2012-00419
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW AND RISK ASSESMENT. RESULTS: THERE HAVE BEEN 33 PREVIOUS COMPLAINTS INVOLVING 35 UNITS SINCE 2004. THE TIP OF THE SCREWDRIVER WAS CONFIRMED TO BE BROKEN, THE BROKEN TIP WAS NOT RETURNED. THE SCREWDRIVER SHOWS TRACES OF WEAR EXPECTED FROM AN INSTRUMENT THAT HAS BEEN IN USE FOR OVER 7 YEARS. 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 DISTAL TIP DEFORMATION IS MOST LIKELY THE RESULT OF NORMAL WEAR DURING ITS LIFE IN THE FIELD. 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 "WHILE PULLING OUT INSTRUMENTS TO TAKE TO SURGERY, WE NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BEEN BROKEN OFF OR WORN OFF. NOT SURE WHEN THIS ACTUALLY OCCURRED, BUT INSTRUMENT IS NO LONGER ACCEPTABLE FOR SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER INSTRUMENT HXX STRYKER SPINE BORDEAUX NA 049086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA