BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM MIS 2.0 REAMER HANDLE-STRYKER/ZIMMER/HALL

    MDR report key: 7121592 · Received December 15, 2017

    Report

    Report Number
    3005180920-2017-00744
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 15, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED ON 27 NOVEMBER 2017 BY R&D PROJECT MANAGER BASED ON THE PICTURES RECEIVED BY THE COMPLAINER: AFTER HAVING SEEN THE IMAGES RECEIVED, I CAME TO THE FOLLOWING CONCLUSIONS: - AN PIN OF ONE OF THE JOINT OF THE SHAFT WAS BROKEN; - THE ROOT CAUSE IS DIFFICULT TO UNDERSTAND. IT MIGHT BE DUE TO A HIGH STRESS IN THIS PARTICULAR CASE. INVESTIGATION PROVIDED BY HPF ON 28 NOVEMBER 2017: BATCH RELEASED ON DATE: 05/16/2017 N. OF PIECES RELEASED: 16 COMMENTS:ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. CONCLUSIONS:THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. ON THE SAME REPORT THEY ALSO REPORTED THE INVESTIGATION BASED ON THE PICTURE SEND THEM. INSPECTION: ANALYZING THE PICTURES ABOVE WE COULD SAY THAT THE UNIVERSAL JOINT IS BROKEN, IN PARTICULAR THE PIN BROKE. CONCLUSION: WE EXCLUDE THE POSSIBILITY THAT THE BREAKAGE HAS BEEN CAUSED BY THE SURGICAL DRILL USE: IT HAS BEEN SHOWED THAT THERE AREN'T ANY STRUCTURAL ISSUES USING THE SURGICAL DRILL. WE SUPPOSE THAT THE BREAKAGE OF THE DEVICE IS DUE TO THE REACHING OF A TWISTING COUPLE HIGHER THAN 25NM DURING THE USAGE (AS MARKED ON THE SHELL OF THE DEVICE). WE TEST THE 100% OF THE MIS REAMER HANDLE ENDURANCE WITH A TWISTING COUPLE OF 30NM. FURTHERMORE WE SUPPOSE THAT THE BREAKAGE HAS BEEN CAUSED BY A MANUAL USE OF THE DEVICE, WITH WHICH IS POSSIBLE TO REACH HIGH TORQUE LEVELS THAT COMPROMISE THE RESISTANCE OF THE MIS. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON 15 DECEMBER 2017: AFTER HAVING DONE THE VISUAL INSPECTION, I CAME TO SAME CONCLUSIONS OF PRELIMINARY INVESTIGATION: - AN PIN OF ONE OF THE JOINT OF THE SHAFT WAS BROKEN; - THE ROOT CAUSE IS DIFFICULT TO UNDERSTAND. IT MIGHT BE DUE TO A HIGH STRESS IN THIS PARTICULAR CASE. HOWEVER AN IMPROVED INSTRUMENT VERSION HAS BEEN DEVELOPED BY MANUFACTURER.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS REAMING THE REAMER HANDLE BROKE. THE INTERNAL KNUCKLE BROKE. THE CASE WAS DELAYED ABOUT 15MIN THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902988 TITANIUM MIS 2.0 REAMER HANDLE-STRYKER/ZIMMER/HALL SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 17H6756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other