BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 3079311 · Received April 25, 2013

    Report

    Report Number
    3003506883-2013-10146
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    August 21, 2012
    Report Date
    August 21, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MANUFACTURING EVALUATION REPORTS THAT THE HELICAL BLADE WAS RECEIVED WITH SOME DAMAGE TO THE NOSE AND FLUTE END AREA OF THE DEVICE. ONE OF THE FULL FLUTES HAS A DEEP GOUGE OR MATERIAL REMOVAL AT THE END OF THE FLUTE. THE TWO OTHER FULL FLUTES SHOW SOME DAMAGE AT THE END OF THE FLUTES, BUT NOT AS SIGNIFICANT AS THE FIRST ONE MENTIONED. SOME MINOR LOSS OF ANODIZE FINISH IS VISIBLE WHERE THE NECK OF THE DEVICE TRANSITIONS TO THE FULL DIAMETER AND ON THE FLAT FEATURE. NO OTHER VISUAL DAMAGE IS NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL ACCEPTANCE CRITERIA AT THE TIME OF MANUFACTURE, WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THAT THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. AS THE DEVICE HISTORY RECORD SHOWS NO COMPLAINT RELATED ANOMALIES, ALL MEASURED PART FEATURES RELEVANT TO THE COMPLAINT ARE CONFORMING, AND THE NOTED VISUAL DAMAGE IS POST-MANUFACTURING, THIS COMPLAINT IS DEEMED INVALID.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAIL PROCEDURE, THE AIMING ARM WAS NOT TARGETING THE HOLE IN THE NAIL APPROPRIATELY. THE HELICAL BLADE MISSED THE HOLE AND WAS DAMAGED AS WELL. THE SURGEON COMPLETED THE PROCEDURE BY TAKING OFF THE AIMING ARM AND FREE HANDED THE INSERTION WITH A NEW HELICAL BLADE. APPROXIMATELY 5 ADDITIONAL MINUTES WERE ADDED TO SURGERY. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178592 11.0MM TI HELICAL BLADE 95MM-STERILE HSB SYNTHES ELMIRA 6967219

    Patients

    Seq Age Sex Outcome Treatment
    1