BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3023480 · Received March 27, 2013

    Report

    Report Number
    1719045-2013-10461
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    November 4, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE HELICAL BLADE COUPLING SCREW EXHIBITS NUMEROUS DEEP DENTS ON THE TOP AND EDGES OF THE KNOB AND THERE ARE CIRCUMFERENTIAL SCRATCHES AROUND THE SHAFT JUST BELOW KNOB TO SHAFT JOINT. THE THREADS ON THE DISTAL END ARE BROKEN OFF AND WERE NOT RETURNED WITH THE COMPLAINT. THE DESIGN EVALUATION REVEALED THE COUPLING SCREW IS DESIGNED TO ATTACH THE TFN BLADE TO THE TFN INSERTER. THE PROXIMAL END OF THE COUPLING SCREW (WITH THE LARGE KNURLED KNOB) IS MEANT TO BE IMPACTED DURING INSERTION. PROPER ASSEMBLY AND INSERTION OF THE TFN BLADE IS DESCRIBED IN THE TECHNIQUE GUIDE. THE COMPLAINT HISTORY SHOWS SEVERAL COMPLAINTS WHERE THE KNURLED PORTION OF THE COUPLING SCREWS FAILED, SUBSEQUENTLY CAUSING SOME DESIGN IMPROVEMENTS TO ADDRESS THE FAILURE. FAILURE CAN BE CAUSED DUE TO REPETITIVE HAMMERING, HAMMERING OFF AXIS, HAMMERING WITH THE COUPLING SCREW NOT FULLY FASTENED, AND USING THE COUPLING SCREW FOR REMOVAL (NOT RECOMMENDED OR ENDORSED BY THE TECHNIQUE GUIDE). THE MATERIALS AND DIMENSIONS SPECIFIED FOR THE COUPLING SCREW ARE APPROPRIATE. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION, THE COMPLAINT IS DEEMED INVALID FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELICAL BLADE COUPLING SCREW SNAPPED OFF DURING DISTRACTION. ALL PIECES WERE RETRIEVED; NO ADDITIONAL TIME WAS ADDED TO SURGERY.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127155 HELICAL BLADE COUPLING SCREW LXH SYNTHES MONUMENT 4831158

    Patients

    Seq Age Sex Outcome Treatment
    1