BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCALIBER BONE SCREW STERILE L260/30 MM THREAD D

    MDR report key: 2934893 · Received January 25, 2013

    Report

    Report Number
    9680825-2013-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 8, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 2012, 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 BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL INVESTIGATION: THE TECHNICAL INVESTIGATION ON THE RETURNED BROKEN SCREW IS CURRENTLY GOING ON. 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. UNFORTUNATELY, THIS INFORMATION HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE 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: 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 2012, 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 BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL INVESTIGATION: THE TECHNICAL INVESTIGATION ON THE RETURNED BROKEN SCREW IS CURRENTLY GOING ON. 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. UNFORTUNATELY, THIS INFORMATION HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE 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 INFORMATION PROVIDED BY THE DISTRIBUTOR INDICATES: (B)(6), DATE OF SURGERY: (B)(6) 2012, BODY PART TO WHICH THE DEVICE WAS APPLIED: TIBIAL DIAPHYSIS. EVENT DESCRIPTION: DURING THE OPERATION, WHEN THE SURGEON TRIED TO INSERT THE BONE SCREW, THE SCREW WAS BROKEN IN TIBIAL DIAPHYSIS OF THE PT. THE OPERATION WAS FINISHED WITH IMPLANTED TIP OF THE BROKEN SCREW IN THE PT'S BONE. A PORTION ON THE BONE SCREW WAS LEFT IN PT BONE, THE PT IS CURRENTLY DOING WELL. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36188 XCALIBER BONE SCREW STERILE L260/30 MM THREAD D XCALIBER BINE SCREW STERILE L260/30 MM JDW ORTHOFIX SRL 99-912630 V1284831

    Patients

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