BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORACLE LATERAL QUICK

    MDR report key: 3003422 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10413
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. LOT NUMBER COULD NOT BE CONFIRMED. THE LOT NUMBER PROVIDED COULD NOT BE CONFIRMED, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE TOLERANCE ON THE THREADED SHAFT COMPONENT AND THE PUSHER AT WORST CASE HAVE CLEARANCE, HOWEVER THE STRAIGHTNESS TOLERANCE ON THE CURRENT DRAWINGS CAN LEAD TO INTERFERENCE CAUSING THE DEVICE TO JAM. CONCLUSION: THIS IS A KNOWN POTENTIAL ISSUE SCHEDULED FOR REVISION.

    Description of Event or Problem · 1

    RECEIVED DEVICE REPORT FROM SYNTHES (B)(4). (B)(6) CLINIC HAD ORACLE LATERAL QUICK INSERTER/DISTRACTOR (P/N 03.809.921) BLOCKED DURING SURGERY WITHOUT HAMMERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87001 ORACLE LATERAL QUICK LXH SYNTHES GMBH 3289534

    Patients

    Seq Age Sex Outcome Treatment
    1