BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS BROACH HANDLE

    MDR report key: 1994325 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00039
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FAILURE ANALYSIS, THE AMIS BROACH HANDLE PIN WAS FOUND TO BE BROKEN. ON THE BASIS OF MEDACTA'S RISK ANALYSIS, THE FAILURE MODE IS UNLIKELY TO CAUSE PT HARM SINCE, IN CASE OF MALFUNCTIONING OF THE BROACH HANDLE, A SECOND BROACH HANDLE IS ALWAYS AVAILABLE IN THE INSTRUMENTATION KIT, PERMITTING THE SURGEON TO COMPLETE THE SURGERY SUCCESSFULLY, AS HAPPENED IN THIS CASE. FROM THE DOCUMENT REVIEW OF LOT 084699 (B)(4), NO PARTICULAR ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE MOBILE PIN OF THE BROACH HANDLE (REF. 01.15.10.0131 - LOT 084699) IS BROKEN. NO PT OR USER INVOLVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIS BROACH HANDLE REUSABLE SURGICAL INSTRUMENT FOR HIP JDI MEDACTA INTERNATIONAL SA NA 084699

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK