BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM

    MDR report key: 3053012 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10629
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 6, 2012
    Report Date
    April 6, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS 04/06/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL FEMUR OSTEOTOMY PROCEDURE, THE SURGEON INSERTED THE SCREW. X-RAYS CONFIRMED THAT THE THREADS OF THE TIP OF THE SCREW BEGAN TO UNRAVEL. THE SURGEON LEFT THE SCREW IN PLACE SINCE HE HAD ACHIEVED GOOD FIXATION.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156599 4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1