BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE SHAFT

    MDR report key: 2886280 · Received December 26, 2012

    Report

    Report Number
    1526439-2012-84060
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TORQUE SHAFT WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. THE CATALOG NUMBER AND LOT LUMBER ARE UNKNOWN. WITHOUT A CATALOG NUMBER AND LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS - FUNCTIONAL REPRESENTATION FROM R&D, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. DEVICE EVALUATED BY MFR: DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE TORQUE SHAFT BROKE OFF INSIDE THE SET SCREW. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQUE SHAFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1