BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 3013468 · Received March 20, 2013

    Report

    Report Number
    3003506883-2013-10066
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. ADDITIONAL INFORMATION: A MANUFACTURING EVALUATION WAS PERFORMED. AS RECEIVED, THE HELIX BLADE SHOWS ANODIZED RUBBED AWAY ON THE SHAFT. SOME MATERIAL DISPLACEMENT AND DAMAGE IS EVIDENT IN THE POCKET FEATURE. THE PRODUCT WAS INVESTIGATED TO THE LATEST DESIGN SPECIFICATIONS. SINCE ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION CANNOT BE MEASURED, THE COMPLAINT IS INDETERMINATE.

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. DEVELOPMENT EVENT EVALUATION: THE VISUAL EXAMINATION OF THE RETURNED PARTS NOTED, THE LOCKING MECHANISM WAS IN THE LOCKED DOWN POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE, AND THE LOCKING TAB WAS SEVERELY BENT AS A RESULT. 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. 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 COMPLAINED DEVICE WAS NOT IMPLANTED, SO THERE IS NO IMPLANT OR EXPLANT DATE.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. ADDITIONAL INFORMATION RECEIVED (B)(4) 2013.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SURGEON WAS TRYING TO INSERT THE HELICAL BLADE THROUGH THE NAIL, BUT IT WOULD NOT ADVANCE COMPLETELY. THE SURGEON BACKED OUT THE HELICAL BLADE, WHICH SHOWED SEVERAL DINGS AND MARKS. HE THEN REMOVED THE NAIL, AND FOUND THAT THE NAILS LOCKING MECHANISM WAS IN THE CORRECT UP POSITION. THE SURGEON THEN INSERTED A NEW NAIL, AND A NEW BLADE, AND NO FURTHER PROBLEMS WERE ENCOUNTERED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115199 11.0MM TI HELICAL BLADE 105MM HSB SYNTHES ELMIRA 6743630

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR