BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT HANDLE

    MDR report key: 5204256 · Received November 5, 2015

    Report

    Report Number
    9680825-2015-00058
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 6, 2015
    Report Date
    November 30, 2015
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. UNFORTUNATELY ALSO THE LOT NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. ORTHOFIX SRL HAS REQUESTED THE DISTRIBUTOR TO PROVIDE FURTHER INFORMATION ON THE EVENT BY COMPLETING THE RELEVANT COMPLAINT REPORT FORM. UNFORTUNATELY THIS INFORMATION HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFORMATION IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. UNFORTUNATELY ALSO THE LOT NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO ORTHOFIX SRL. A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS IT HAS NOT BEEN MADE AVAILABLE FOR THE TECHNICAL EVALUATION. MEDICAL EVALUATION A COMPLETE MEDICAL EVALUATION OF THE EVENT WAS NOT POSSIBLE DUE TO THE LIMITED INFORMATION PROVIDED. MANUFACTURER FINAL COMMENTS. BOTH TECHNICAL AND MEDICAL EVALUATIONS WERE NOT COMPLETED DUE TO THE LIMITED INFORMATION PROVIDED. ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT, SUCH AS CODE AND BATCH NUMBER OF THE DEVICE INVOLVED; PATIENT DIAGNOSIS; SURGERY DESCRIPTION; BODY PART TO WHICH DEVICE WAS APPLIED; PATIENT INFORMATION (AGE, SEX, WEIGHT AND HEIGHT); INFORMATION ON PATIENT ADVERSE EFFECTS, IF ANY; COPIES OF THE OPERATIVE REPORT AND COPIES OF THE PRE AND POST-OPERATIVE X-RAYS; INFORMATION ON PATIENT CURRENT HEALTH CONDITION AND DEVICE AVAILABILITY FOR THE TECHNICAL EVALUATION. UNFORTUNATELY NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE SO FAR. BASED ON THE INFORMATION AVAILABLE ON THE EVENT, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENT NOTIFIED. IF FURTHER INFORMATION AND/OR THE DEVICE INVOLVED BECOME AVAILABLE, ORTHOFIX SRL WILL FINALIZE THE INVESTIGATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. (B)(4)

    Description of Event or Problem · 1

    THE INFORMATION WAS CAPTURED WITHIN AN E-MAIL RECEIVED FROM A SURGEON ON (B)(6) AND INDICATES: "YESTERDAY ONE OF MY SENIOR COLLEAGUES HAD A FAILURE IN PLACING THE STATIC DISTAL SCREW." NO FURTHER INFORMATION HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION WAS CAPTURED WITHIN AN E-MAIL RECEIVED FROM A SURGEON ON OCTOBER 7TH AND INDICATES: "YESTERDAY ONE OF MY SENIOR COLLEAGUES HAD A FAILURE IN PLACING THE STATIC DISTAL SCREW." TO THE E-MAIL IT WAS ATTACHED AN X-RAY IMAGE WITH NO SPECIFIC REFERENCE TO ANY OF THE COMPLAINED EVENTS. NO FURTHER INFORMATION HAS BEEN PROVIDED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733754 RADIOLUCENT HANDLE RADIOLUCENT HANDLE HSB ORTHOFIX SRL 17915 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1