BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER

    MDR report key: 3032203 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-10525
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER CAREGIVERS

    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. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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. 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 1522. 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. ORIGINAL AWARENESS DATE IS 08/06/2011: NEW INFORMATION WAS RECEIVED ON 8/15/2013 AND 9/6/2013.

    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 1 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.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137203 12MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER HSB SYNTHES MONUMENT 6652613

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR