BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP IMPACTING RING

    MDR report key: 2223496 · Received July 22, 2011

    Report

    Report Number
    3005180920-2011-00039
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREAD OF THE IMPACTING RING WAS DAMAGED (THREADS WERE STRIPPED). THE SURGEON WAS IMPACTING FOR A LONG TIME BECAUSE THE PT'S ACETABULUM WAS TIGHT AND THE CUP WOULD NOT SEAT RIGHT; WHEN THE SURGEON ATTEMPTED TO REMOVE THE 52MM IMPACTING RING FROM THE CUP USING THE MULTI-FUNCTION HANDLES, THE RING WAS STUCK IN THE CUP DUE TO THE LACK OF THREAD PURCHASE. THE SURGEON USED ANOTHER INSTRUMENT AND WAS EVENTUALLY ABLE TO REMOVE THE 52MM IMPACTING RING FROM THE CUP. HE THEN PROCEEDED TO IMPACT THE 52MM CUP USING ANOTHER IMPACTING INSTRUMENT, AVAILABLE BETWEEN THE INSTRUMENTATION AT DISPOSAL. THE SURGERY WAS COMPLETED SUCCESSFULLY W/O ANY HARM FOR THE PT. IT IS HIGHLY LIKELY THAT THE ATTEMPTS TO IMPACT FOR A LONG TIME CAUSED SOME PROBLEMS TO THE THREAD OF THE IMPACTING RING AND THIS BRING TO THE FURTHER PROBLEMS THE SURGEON HAD IN REMOVING THE IMPACTING RING FROM THE CUP.

    Description of Event or Problem · 1

    THE IMPACTING RING INSTRUMENT BROKE IN-SITU AFTER IMPACTING THE CUP. THE SURGEON WAS NOT IMMEDIATELY ABLE TO REMOVE IT NORMALLY WITH THE IMPACTOR HANDLE DUE TO LACK OF THREAD PURCHASE. TO SOLVE THE ISSUES, ADD'L STEPS WERE QUANTIFIED IN ABOUT 30 MINS. HOWEVER, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY HARM FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP IMPACTING RING SURGICAL REUSABLE INSTRUMENT FOR HIP HWA MEDACTA INTERNATIONAL SA 097066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other