BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 3003653 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10044
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR REVIEW PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL EXAMINATION REVEALED EVIDENCE OF DAMAGE TO THE TIP OF THE SCREW. THERE ARE SPOTS/CONTAMINATION ON THE SHAFT. BASED ON THE DHR REVIEW, THE EVALUATION PERFORMED AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT TIBIAL PLATEAU PROCEDURE WITH THE SURGEON INSERTING THE 3.7 MM CANNULATED LOCKING SCREW; THE SCREW SHAFT BROKE. ATTEMPTED TO USE THE CONICAL EXTRACTION SCREW TO REMOVE THE SHAFT AND IT ALSO BROKE. THE PIECES OF THE CONICAL EXTRACTION SCREW WERE RETRIEVED AND THE SHAFT OF THE CANNULATED SCREW REMAINS IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88206 CONICAL EXTRACTION SCREW HWC SYNTHES MONUMENT U105497

    Patients

    Seq Age Sex Outcome Treatment
    1