BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR-M10 (HPF)

    MDR report key: 8184600 · Received December 20, 2018

    Report

    Report Number
    3005180920-2018-01025
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 23, 2018
    Report Date
    February 7, 2019
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT THE CARDAN JOINT OF THE SCREWDRIVER IS BROKEN, IN ADDITION ALSO THE THREADED PART TERMINAL IS SCRATCHED. IT SEEMS THAT THE INSTRUMENT HAS BEEN USED WITH TOO MUCH TORQUE. THE INSTRUMENT IS CE MARKED BY SUPPLIER

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED BY THE MANUFACTURER HPF: BATCH RELEASED ON DATE: 27/04/2017. N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. THIS IS NOT THE FIRST COMPLAINT ON THIS BATCH. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. ANALYZING THE PICTURES ABOVE, WE NOTICE THAT THE DAMAGED PART IS THE JOINT OF THE ROTATION MECHANISM. WE SUPPOSE THAT THE RUPTURE CONCERNING THE LASER WELDING IS DUE TO AN IMPROPER USE OF THE INSTRUMENT. WE SUPPOSE THAT AN HIGHER ROTATION FORCE HAD BEEN EXERTED EXCEEDING THE RESISTANCE OF THE DEVICE. TO STRENGTHEN UP THE DEVICE, HPF HAS INTRODUCED A MODIFICATION THAT REPLACE THE 2 HALF-PINS WITH A CROSSING PIN. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: LOOKING AT THE IMAGES ATTACHED TO THIS COMPLAINT IT IS EVALUABLE THAT THE CARDAN JOINT OF THE SCREWDRIVER IS BROKEN. MORE DETAILS ABOUT THE POSSIBLE ROOT CAUSE WILL BE ADDED DURING THE VISUAL INSPECTION. THE INSTRUMENT IS CE MARKED BY SUPPLIER.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS IMPACTING THE ACETABULAR COMPONENT THE CUP IMPACTOR LOCKING MECHANISM BROKE AND FELL ONTO THE FLOOR. A BACK-UP INSTRUMENT WAS USED AND THE SURGERY COMPLETED SUCCESSFULLY. THE DELAY WOULD BE APPROXIMATELY OF 30 MINUTES AS THEY HAD TO REPLACE THE CUP IMPACTOR AND TO DO THE IMAGING TO CONFIRM THAT THERE WAS NO FOREIGN METAL RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023889 AMIS CUP IMPACTOR-M10 (HPF) SURGICAL INSTRUMENT FOR HIP SURGERIES LXH HPF SPA 17H5861

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other