BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR-M8

    MDR report key: 6944520 · Received October 12, 2017

    Report

    Report Number
    3005180920-2017-00568
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 12, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06 OCTOBER 2017, HPF (MANUFACTURER OF THE INSTRUMENT) PROVIDED THE FOLLOWING INVESTIGATION: BATCH RELEASED ON DATE: 08/05/2017, 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. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. INSPECTION: ANALYZING THE PICTURES OF THE FAULTY INSTRUMENT, WE NOTICED THAT THE CARDAN'S PINS CRACKED CAUSING THE INSTRUMENT BRAKEAGE. IN PARTICULAR, THE FAILURE OF THE PINS' LASER WELDING PERMITTED THE PINS' EXIT FROM THEIR PLACE WITH CONSEQUENT DISCONNECTION BETWEEN THE PARTS. CONCLUSION: WE SUPPOSE THAT THE RUPTURE 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. WE BROUGHT A CHANGE IN THE PROJECT. WE SUBSTITUTED THE 2 HALF PIN WITH A PASSING PIN THAT ASSURE MORE RESISTANCE TO THE CARDAN. ON 06 OCTOBER 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: DURING THE INSPECTION, IT IS EVALUATED A BREAKAGE OF THE CARDAN JOINT: IN PARTICOLAR THE LASER WELDING HAS BEEN BROKEN AND THE PIN IS DISLOCATED. IT IS POSSIBLE TO SUPPOSE THAT THE SURGEON USED THE INSTRUMENT APPLYING TOO MUCH TORSIONAL MOMENT AND THIS CAUSED THE BREAKAGE. THE INSTRUMENT IS CE MARKED BY HPF.

    Description of Event or Problem · 1

    DURING THE CUP IMPLANTATION INTO THE ACETABULUM, THE PIN OF THE CARDANIC MECHANISM BROKE AND FELL INTO THE WOUND. FORTUNATELY, THE PART WAS FOUND AND REMOVED FROM THE PATIENT. NOT CRITICAL DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724595 AMIS CUP IMPACTOR-M8 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 17H6209

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other