BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMING ROD MEASURING DEVICE

    MDR report key: 3082192 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10947
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. MANUFACTURING EVALUATION REPORTS THE REAMING ROD MEASURING DEVICE WAS RECEIVED WITH SIGNS OF WEAR. THE BOTTOM PORTION OF THE THREAD ON THE LOCKING DEVICE APPEARED DAMAGED. BASED ON THE UNKNOWN CAUSE, THE EVALUATION, AND THE CONDITION OF THE INSTRUMENT, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE THREADED STUD THAT CONNECTS THE DISTAL AND MIDDLE SEGMENTS HAS PULLED THROUGH THE WELD JOINT IN THE MIDDLE SECTION. WHEN THE KNOB IS TIGHTENED AND THE OPERATOR ATTEMPTS TO FOLD THE RULER, THE DIRECTION OF FOLDING CAN EITHER LOOSEN OR TIGHTEN THE KNOB. IF THE DIRECTION OF FOLDING IS RANDOMLY SELECTED SUCH THAT IT TIGHTENS THEN IT MAY BE POSSIBLE THROUGH REPEATED LOADINGS TO OVERLOAD THE MATERIAL STRENGTH OF THE RULER AND PULL THE THREADED POST FREE. FOLDING WITHOUT LOOSENING IS A CONSIDERED MISUSE. WITH THIS DEVICE RESIDING IN MULTIPLE SYSTEMS, THE PREDICTION OF THE FREQUENCY IS NOT DETERMINED DUE TO THE DISCRETION OF THE SURGEON ON WHICH METHOD OR DEVICE IS USED TO DETERMINE LENGTH OF NAIL THAT IS NEEDED. THE USAGE CAN NOT BE DETERMINED ACCURATELY. CURRENT INSTRUCTIONS FOR USE DO NOT STATE THAT THE TIGHTENING KNOBS MUST BE FULLY LOOSENED WHILE PIVOTING THE ARMS OF THE DEVICE. THE LOW FREQUENCY AND LOW SEVERITY INDICATE THAT THE DESIGN IS ADEQUATE AS IS. THIS COMPLAINT IS DEEMED VALID FROM A DESIGN PERSPECTIVE. A CAPA RISK ASSESSMENT WAS COMPLETED FOR THE IDENTIFIED NON-CONFORMANCE. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED.

    Additional Manufacturer Narrative · 1

    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 DURING A TROCHANTERIC FIXATION NAIL (TFN), WHILE SETTING UP THE DEVICE TO MEASURE THE REAMING ROD THE LOCKING NUT BROKE OFF AT THE WELD. NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, WITHOUT PATIENT HARM THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184893 REAMING ROD MEASURING DEVICE LXH SYNTHES MONUMENT 6511942

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR