BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 115MM

    MDR report key: 3020817 · Received March 26, 2013

    Report

    Report Number
    3003506883-2013-10068
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    November 13, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. BASED ON EXAMINATION OF THE RETURNED PARTS, THE LOCKING MECHANISM WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE. THE LOCKING TAB WAS BENT TOWARD THE PROXIMAL/MEDIAL HOLE AS A RESULT AND NOW PARTIALLY BLOCKS THE 11 MM HOLE FOR THE HELICAL BLADE. FOR THIS COMPLAINT, THE LOCKING MECHANISM WAS ALREADY DEPLOYED. THEREFORE, THIS EVALUATION IS INVALID FROM A DESIGN PERSPECTIVE. A MANUFACTURING EVALUATION WAS ALSO PERFORMED. THE AS RECEIVED CONDITION OF 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 MEET SPECIFICATION, THE COMPLAINT IS INVALID. ADDITIONAL NARRATIVE: 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

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, A NAIL WAS INSERTED IN THE FEMUR. THE HELICAL BLADE STOPPED PARTWAY THROUGH INSERTION INTO THE NAIL. THE SURGEON WAS ABLE TO REMOVE THE HELICAL BLADE AND NAIL BY MALLETING. THE SURGEON INSERTED A BRAND NEW NAIL AND BLADE. THERE WERE NO FURTHER PROBLEMS. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123814 11.0MM TI HELICAL BLADE 115MM HSB SYNTHES ELMIRA 6656750

    Patients

    Seq Age Sex Outcome Treatment
    1