BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCALIBER ARTICULATED ANKLE KIT STERILE

    MDR report key: 2660924 · Received July 11, 2012

    Report

    Report Number
    9680825-2012-00025
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Date of Event
    April 6, 2012
    Report Date
    July 10, 2012
    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 2011, WAS COMPRISED OF 45 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL HAS REQUESTED TO THE DISTRIBUTOR INVOLVED PT'S DETAILS INCLUDING AN UPDATE ON THE CURRENT HEALTH CONDITION AND COPY OF THE PRE AND POST OPERATIVE X-RAYS AND THE DEVICE AVAILABILITY FOR THE TECHNICAL INVESTIGATION. UNFORTUNATELY, THIS INFO HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFO AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE 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 DISTRIBUTOR INDICATES: DURING THE OPERATION, WHEN WE TRIED TO FIX THE CLAMP SCREW OF THE FIXATOR CODE 99-91047, THE MAIN PART OF THE DEVICE SUDDENLY CRACKED WITHOUT BEING SWIVELED REPEATEDLY. NO ADVERSE EFFECTS FOR THE PT AS A REPLACEMENT PART WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCALIBER ARTICULATED ANKLE KIT STERILE XCALIBER ARTICULATED ANKLE KIT STERILE JDW ORTHOFIX SRL 99-91047 V1233443

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN NO INFO HAS BEEN MADE AVAILABLE