BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR-M8 (HPF)

    MDR report key: 8184597 · Received December 20, 2018

    Report

    Report Number
    3005180920-2018-01023
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 20, 2018
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: ON THE BASIS OF WHAT IS SHOWED IN THE PROVIDED IMAGES IT IS VISIBLE THAT THE WELDING OF THE PIN WHICH CONNECTS THE PLATE TO THE CUP IMPACTOR BODY IS BROKEN. BOTH THE PIN AND THE SPRING ARE DISLOCATED AND ARE VISIBLE IN THE IMAGES. FURTHER DETAILS WILL BE ADDED DURING THE VISUAL INSPECTION. THE INSTRUMENT IS CE MARKED BY SUPPLIER. INVESTIGATION PERFORMED BY THE MANUFACTURER HPF: BATCH RELEASED ON DATE: 08/05/2017 N. OF PIECES RELEASED: 14 ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. HAVE WE RECEIVED OTHER COMPLAINT FOR THIS BATCH? YES. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. LOOKING AT THE PICTURE THE LASER WELDING FAILED. WE SUPPOSE THAT THE PROBLEM MAYBE HAD BEEN CAUSED BY A NOT PERFECT LASER WELDING. HPF HAS IMPROVED THE RELIABILITY OF THE LASER WELDING PROCESS BY INTEGRATING A 450W FIBER-SOURCE LASER WELDING MACHINE.

    Description of Event or Problem · 1

    DURING THE PRIMARY HIP SURGERY, AFTER SUCCESSFULLY IMPACTING THE CUP, IT WAS DISCOVERED THAT THE CUP IMPACTOR WAS BROKEN (PLATE). NO FRAGMENTS FELL INTO THE PATIENT AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023897 AMIS CUP IMPACTOR-M8 (HPF) SURGICAL INSTRUMENT FOR HIP SURGERIES LXH HPF SPA 17H6209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other