BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 3062945 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10671
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. (B)(4). A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE TAB ON THE LOCKING MECHANISM HAS BEEN BROKEN OFF AND THE MEDIAL SIDE OF THE BREAK IS BENT TOWARD THE MEDIAL HOLE. THERE ARE NO MARKS ON THE EDGES OF THE 11 MM HOLE ON EITHER SIDE. BASED ON EXAMINATION OF THE RETURNED PART, THE LOCKING MECHANISM IN THE NAIL WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE SCREW AND THE LOCKING TAB WAS SHEARED OFF AS A RESULT. THIS ISSUE HAS BEEN NOTED ON SEVERAL PREVIOUS COMPLAINTS FOR THE TFN NAILS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 A TFN PROCEDURE, THE SURGEON INSERTED THE NAIL AND WAS ADVANCING THE HELICAL BLADE THROUGH THE NAIL. THE HELICAL BLADE BECAME STUCK IN THE NAIL. THE LOCKING MECHANISM ON THE NAIL WAS DOWN AND DEPLOYED. SURGEON BACKED OUT THE HELICAL BLADE AND THE NAIL AND USED A NEW NAIL TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164773 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6766946

    Patients

    Seq Age Sex Outcome Treatment
    1