BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 3058536 · Received April 15, 2013

    Report

    Report Number
    3003506883-2013-10096
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11.0MM HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. ADDITIONAL COMMON DEVICE NAME: HWS.

    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.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, THE SURGEON INSERTED THE 11 MM 130° CANNULATED TROCHANTERIC NAIL AND THEN PROCEEDED TO INSERT THE 11.0 MM HELICAL BLADE. THE BLADE GOT STUCK HALFWAY THROUGH THE NAIL. SURGEON REMOVED THE BLADE AND THE NAIL, SELECTED ANOTHER NAIL AND BLADE AND COMPLETED THE PROCEDURE. THERE WAS NO EXTENDED TIME AND NO EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161481 11.0MM TI HELICAL BLADE 105MM HSB SYNTHES ELMIRA 6552088

    Patients

    Seq Age Sex Outcome Treatment
    1