BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 2993969 · Received March 8, 2013

    Report

    Report Number
    3003506883-2013-10056
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED BASED ON EXAMINATION OF THE RETURNED PARTS, THE LOCKING MECHANISM WAS IN THE LOCKED DOWN POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE. THE LOCKING TAB WAS SEVERELY BENT AND BROKE OFF AS A RESULT. THIS COMPLAINT IS VALID, AND 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. ADDITIONAL NARRATIVE PRODUCT EVALUATION FOR THIS COMPLAINT REVEALED THE LOCKING MECHANISM WAS ALREADY DEPLOYED. THEREFORE, THIS EVALUATION IS INVALID FROM A DESIGN PERSPECTIVE. MANUFACTURING EVALUATION INVESTIGATED THE PRODUCT TO THE LATEST DESIGN SPECIFICATIONS VIA INSPECTION SHEETS (B)(4). SINCE ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION MEET SPECIFICATION, THE COMPLAINT IS INVALID. CORRECTED DATA: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE THE HELICAL BLADE WOULD ONLY ADVANCE THREE FOURTHS OF THE WAY DOWN, AND THE BLADE GOT STUCK IN THE NAIL. THE SURGEON INSERTED THE NAIL IN PATIENT, THE LOCKING MECHANISM ON BRAND NEW NAIL WAS DOWN AND DEPLOYED WHEN OPENED. SURGEON BACKED UP THE LOCKING MECHANISM ON THE NAIL A LITTLE UNTIL IT STOPPED, HE THEN INSERTED THE NAIL. IT WAS THEN WHEN HE WENT TO INSERT THE HELICAL BLADE AND THE BLADE WOULD ONLY ADVANCE ABOUT PART OF THE WAY AND THE BLADE GOT STUCK IN THE NAIL. SURGEON USED THE EXTRACTOR TO BACK OUT THE BLADE AND HE REMOVED THE NAIL. SURGEON USED A BRAND NEW NAIL AND BLADE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. SURGERY WAS EXTENDED BY TEN TO FIFTEEN MINUTES, WITH NO HARM TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98694 11.0MM TI HELICAL BLADE 105MM-STERILE HSB SYNTHES ELMIRA 6776734

    Patients

    Seq Age Sex Outcome Treatment
    1