BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS-EX

    MDR report key: 3031809 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-10523
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PRODUCT DEVELOPMENT EVALUATION REVEALS THE SAMPLE WAS RECEIVED WITH BREAKAGE AT THE TIP. NO OTHER SIGNS OF DISTRESS OR DAMAGE WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS ISSUE WAS PREVIOUSLY EVALUATED AND DEEMED VALID. A DESIGN CHANGE WAS INSTITUTED ADDRESSING THE DURABILITY OF THE ALIGNMENT TANG. DESIGN IS ADEQUATE FOR THE INSTRUMENTS INTENDED PURPOSE. A CAPA RISK ASSESSMENT WAS COMPLETED. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IM NAILING OF A RIGHT FEMUR, WHILE SURGEON WAS TRYING TO REMOVE NAIL, THE TOOTH WHERE THE HANDLE CONNECTS TO THE NAIL BROKE OFF.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4). PROCEDURE WAS REPORTED TO BE INTER-MEDULLARY NAILING OF A RIGHT FEMUR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134940 PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS-EX LXH SYNTHES MONUMENT 1751300

    Patients

    Seq Age Sex Outcome Treatment
    1