BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTRUMENT ADAPTER, STARLOCK INTERFACE

    MDR report key: 2101171 · Received May 17, 2011

    Report

    Report Number
    8043933-2011-00006
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K010602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THE HOSPITAL REPORTS NO NEGATIVE OUTCOME FOR THE PT, THERE HAS BEEN NO PT OR USER INJURY REPORTED AT THIS HOSPITAL NOR REPORTED BY ANY OTHER HOSPITAL, THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE OR WITH THIS SPECIFIC DEVICE FOR THE INTENDED USE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED YET BY BRAINLAB. THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE OR WITH THIS SPECIFIC DEVICE FOR THE INTENDED USE. ACCORDINGLY, THERE ARE NO REMEDIAL ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME. NEVERTHELESS BRAINLAB INTENDS TO CONTINUE TO INVESTIGATE THE SPECIFIC ROOT CAUSE IN COOPERATION WITH THE HOSPITAL.

    Description of Event or Problem · 1

    THE BRAINLAB ADAPTER, THAT WAS MOUNTED TO THE SURGEON'S INSTRUMENT TO FIXATE THE REFERENCE ARRAY USED FOR IMAGE GUIDED HIP SURGERY BROKE DURING THE SURGERY AND A PIECE FELL INTO THE PT'S BODY. THE PIECE WAS FOUND AND REMOVED DURING THE SAME SURGERY, THERE WAS NO NEGATIVE OUTCOME FOR THE PT REPORTED. THE EXACT OCCURRENCE DATE IS NOT KNOWN TO BRAINLAB. THE HOSPITAL DID NOT YET COMMUNICATE SPECIFICS OF USE THAT COULD HAVE CONTRIBUTED TO THE BRAINLAB ADAPTER TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT ADAPTER, STARLOCK INTERFACE IMAGED GUIDED SURGERY SYSTEM / INSTRUMENT HAW BRAINLAB AG 55080D NA

    Patients

    Seq Age Sex Outcome Treatment
    1