BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCALIBER ARTICULATED ANKLE KIT STERILE

    MDR report key: 3669558 · Received December 18, 2013

    Report

    Report Number
    9680825-2013-00041
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHFIX SRL. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ONGOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE TECHNICAL EVALUATION WILL BECOME AVAILABLE, ORTHOFIX SRL WILL PROVIDED YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF SURGERY: (B)(6) 2013. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. PT INFO: (B)(6)MALE PT. EVENT DESCRIPTION: IN APPLYING 99-91047, WHEN SURGEON WAS LOCKING BALL-JOINTS WITH THE ALLEN WRENCH, THE CAM WAS TURNED TOWARDS THE THICKER SECTION OF THE COLOURED INSERT, AND THE CAMS IS AT 50% OF THE WAY ACROSS THE RECESS, BUT ANGLE CLAMP BURST. NO ADVERSE EFFECT TO PT, A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. COPIES OF OPERATIVE REPORT AND COPIES OF THE PRE AND POST OPERATIVE XRAYS ARE NOT AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661286 XCALIBER ARTICULATED ANKLE KIT STERILE XCALIBER ARTICULATED ANKLE KIT STERILE JDW ORTHOFIX SRL 99-91047 V1343031

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR