BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3041683 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10603
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    September 27, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY SEATING THE TFN BECAUSE THE LOCKING MECHANISM OF THE TFN WAS ENGAGED PRIOR TO THE START OF THE PROCEDURE. THE SURGEON EXPLANTED THE TFN, ADJUSTED THE LOCKING MECHANISM, INSPECTED IT FOR DAMAGE (THERE WAS NO DAMAGE FOUND) AND THEN RE-IMPLANTED THE TFN. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 5-8 MINUTES.

    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
    144136 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1