BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM

    MDR report key: 11670078 · Received April 15, 2021

    Report

    Report Number
    0008031020-2021-00153
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 21, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327086812
    PMA / PMN Number
    K180500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED AND NO OTHER EVIDENCES WERE PROVIDED FOR INVESTIGATION. A POTENTIAL NON-CONFORMITY REPORT WAS INITIATED TO ADDRESS SIMILAR EVENTS IN THE PAST. THE COMPREHENSIVE ROOT CAUSE ANALYSIS OF THE POTENTIAL NCR INCLUDED A SURFACE AND MICROSTRUCTURE ANALYSIS AS WELL AS NANO-INDENT HARDNESS MEASUREMENT OF VARIAX1 AND VARIAX2 SCREW SAMPLES BY THE FRAUNHOFER INSTITUTE ON BEHALF OF STRYKER. FURTHER INTERNAL INVESTIGATION EFFORTS WERE FOCUSING ON THE ANODIZATION COLOR DIFFERENCE BETWEEN VARIAX1 AND VARIAX2 SCREWS. SIGNIFICANT DIFFERENCES BETWEEN THE SCREWS WHICH COULD RESULT IN THE REPORTED COMPLAINTS HAVE NOT BEEN REVEALED IN EITHER FRAUNHOFER OR STRYKER INVESTIGATIONS. EXCESSIVE IN-HOUSE HANDLING AND BENCH TESTING WITH VARIAX2 SCREWS FROM VARIOUS MANUFACTURING BATCHES SHOWED THAT LOCKING IS ACHIEVED AS INTENDED. THE DESIRED INCREASE IN TORQUE INDICATING TO THE CUSTOMER THAT THE SCREW IS LOCKING IN THE PLATE, CAN BE CONFIRMED. THE BATCH RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. CONSIDERING THE INFORMATION GIVEN AND BASED ON THE ABOVE INVESTIGATIONS A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER SUBSTANTIAL INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573517 LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM SCREW, FIXATION, BONE HWC STRYKER GMBH 657312 UNKNOWN 07613327086812

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR