BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL TITANIUM MIS 2.0 REAMER HANDLE-STRYKER/ZIMMER/HALL

    MDR report key: 7067364 · Received November 29, 2017

    Report

    Report Number
    3005180920-2017-00711
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 29, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 27 NOVEMBER 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS. AFTER HAVING DONE THE VISUAL INSPECTION, I CAME TO THE FOLLOWING CONCLUSIONS: -A 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. THE MANUFACTURER WAS ALERTED ON (B)(4) 2017. PICTURES SENT THEM ON THE 17TH NOVEMBER 2017. ON 28 NOVEMBER 2017 THEY SEND US THE FINAL REPORT REPORTING AS FOLLOWS: DOCUMENT REVIEW BATCH RELEASED ON DATE: 30/04/2015 N. OF PIECES RELEASED: (B)(4) COMMENTS: ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. WE HAVE ALREADY RECEIVED OTHER COMPLAINT FOR THIS BATCH CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. INSPECTION: ANALYZING THE PICTURES 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. HPF HAS LAUNCHED THE MIS 3.0 IMPROVING THE PERFORMANCES OF THE REAMER HANDLE, TOUGHEN UP THE INTERNAL ROTATION MECHANISM AND IMPROVING THE LUBRICATION SYSTEM. TESTS HAVE BEEN PERFORMED PROVING THAT IF USAGE AND MAINTENANCE INSTRUCTION ARE FOLLOWED, THERE IS NO RISK OF ANOMALOUS PERFORMANCE LOSSES.

    Description of Event or Problem · 1

    DURING SURGERY THE INTERNAL MECHANISM OF THE INSTRUMENT BROKE IN HALF. THE SURGEON USED A SECONDARY INSTRUMENT TO COMPLETE THE SURGERY. THERE WAS A 20 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845503 HIP GENERAL TITANIUM MIS 2.0 REAMER HANDLE-STRYKER/ZIMMER/HALL SURGICAL HIP INSTRUMENT LXH HPF S.P.A. 15H4519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other