BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 3032201 · Received April 3, 2013

    Report

    Report Number
    3003506883-2013-10088
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    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 THAT THE PART MEETS DESIGN INTENT AND BASED ON THE DETAILS OF THE REPORT, DID NOT CONTRIBUTE TO COMPLAINT CONDITION. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ISSUE WITH THE LOCKING MECHANISM IN THE NAIL. THIS PARTICULAR PART DID NOT CONTRIBUTE TO COMPLAINT CONDITION. ACTUAL DEVICE WAS NOT EVALUATED; HOWEVER THE PRODUCT DEVELOPMENT EVALUATION IS BASED ON PREVIOUS EVALUATIONS FOR THE SAME PROBLEM AND SAME DEVICE.

    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: ADDITIONAL PRODUCT EVALUATION REVEALED THE LOCKING MECHANISM WAS ALREADY DEPLOYED. THEREFORE, THIS EVALUATION IS INVALID FROM A DESIGN PERSPECTIVE. 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. THIS MANUFACTURING INVESTIGATION IS BEING PERFORMED AS PART OF STOCK EVALUATION (B)(4). THIS COMPLAINT IS BEING REVIEWED TO CONFIRM THAT THE PRODUCT IS WITHIN ALL FINAL SPECIFICATIONS. PRODUCT WAS INVESTIGATED TO THE LATEST DESIGN SPECIFICATIONS VIA INSPECTION SHEETS (B)(4). THE DAMAGE TO THE POCKET FEATURE PREVENTS MEASUREMENT OF L5, W3 AND H1. SINCE ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION CANNOT BE MEASURED, THE COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN CASE, THE SURGEON WAS TRYING TO INSERT THE HELICAL BLADE, WHEN THE HELICAL BLADE GOT STUCK ON THE NAIL AND WOULD NOT ADVANCE. X-RAYS SHOWED THE LOCKING MECHANISM WAS ALREADY IN THE DOWN POSITION. THE TFN NAIL AND HELICAL BLADE WERE REMOVED AND REPLACED WITH A NEW NAIL AND BLADE WITH NO FURTHER PROBLEM. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THE FRACTURE WAS REPORTED TO HAVE COMPLETELY HEALED. IT WAS FURTHER REPORTED A BONE GRAFT WAS NOT USED AND THERE WAS NO POSTOPERATIVE IMMOBILITY. PATIENT RESTRICTIONS WERE WEIGHT BEARING AS TOLERATED AND ELEVATION OF LOWER EXTREMITY. THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136810 11.0MM TI HELICAL BLADE 105MM-STERILE HSB SYNTHES ELMIRA 6639357

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR