BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM/8.0MM PROTECTION SLEEVE

    MDR report key: 3021363 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-10984
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. ADDITIONAL INFORMATION: PRODUCT DEVELOPMENT EVENT EVALUATION SHOWED THAT THERE HAVE BEEN 14,500 RAFN NAILS INSERTED IN THE PAST 12 MONTHS. SYSTEM IS DESIGNED WITHIN 3 SIGMA ACCURACY. THEREFORE 99.75 OF PROCEDURES WILL TARGET WITHOUT COMPLICATION. THEREFORE, (B)(4) POSSIBLE COMPLAINTS COULD BE REPORTED AND FIT THE DESIGN CRITERIA. DESIGN IS ADEQUATE FOR INTENDED USAGE. INSTRUMENTS WERE NOT AVAILABLE TO CHECK FOR DAMAGE. INSTRUMENTS WERE NOT NOTED AS NEW AND THEREFORE HAD BEEN USED PREVIOUSLY WITHOUT COMPLAINT. INSTRUMENTS SERVE AS GUIDANCE AND POOR SURGICAL TECHNIQUE CAN OVER-RIDE THE GUIDANCE AND CAUSE TARGETING TROUBLE WITH ANY INSTRUMENTATION. CONCLUSION; INDETERMINATE. ROOT CAUSE CANNOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A RETROGRADE NAILING PROCEDURE SURGEON INSERTED THE NAIL AND WAS GOING TO INSERT THE SCREW DISTALLY WHEN THE SURGEON COULD NOT LINE UP WITH THE HOLE IN THE NAIL TO INSERT THE SCREW. THE CONSTRUCT CONSISTED OF INSERTION HANDLE (357.112), AIMING ARM (357.096), TROCAR (357.098), PROTECTION SLEEVE (357.76) AND DRILL SLEEVE (357.097). SURGEON REMOVED THE CONSTRUCT AND DRILLED AND INSERTED THE NAIL FREEHAND. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. SURGEON STATED POSSIBILITY OF THE TROCAR NOT BEING ALL THE WAY DOWN DUE TO A LOT OF TISSUE BEING ON THE WAY. PLEASE NOTE THE AIMING ARM, INSERTION HANDLE AND PROTECTION SLEEVE ARE ALL SERVICE AND REPAIR ITEMS AND WILL NOT BE RETURNED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123979 11.0MM/8.0MM PROTECTION SLEEVE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1