BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCALIBER ARTICULATED ANKLE KIT STERILE

    MDR report key: 3605577 · Received December 10, 2013

    Report

    Report Number
    9680825-2013-00036
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    August 7, 2013
    Report Date
    December 6, 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 EVAL: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN REC'D BY ORTHOFIX SRL. THE TECHNICAL EVAL WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MFR COMMENTS: ORTHOFIX SRL HAS REQUESTED FURTHER INFO ON THE EVENT SUCH AS COPIES OF THE OPERATIVE REPORT AND COPIES OF THE PRE AND POST-OPERATIVE X-RAYS; INFO ON PT CURRENT HEALTH CONDITION AND DEVICE AVAILABILITY FOR THE TECHNICAL EVAL. AS SOON AS FURTHER INFO WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A F/U REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL, (B)(6) UNIVERSITY. SURGEON NAME: (B)(6). DATE OF SURGERY: (B)(6) 2013. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. PT INFO: A (B)(6) FEMALE PT, (B)(6). EVENT DESCRIPTION: DURING SURGERY, WHEN THE SURGEON TIGHTENED THE FIXATOR, IT CRACKED AND THE LOWER SPHERICAL JOINT CANNOT BE FIXED TIGHTLY. ON (B)(6) 2013, ORTHOFIX SRL REC'D THE FOLLOWING ADD'L INFO: SURGERY DESCRIPTION: FRACTURE TREATMENT. NO ADVERSE EFFECTS TO PT, A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. MFR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645219 XCALIBER ARTICULATED ANKLE KIT STERILE XCALIBER ARTICULATED ANKLE KIT STERILE JDW ORTHOFIX SRL 99-91047 V1339352

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO INFO HAS BEEN MADE AVAILABLE.