BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE

    MDR report key: 3083389 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11140
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 6, 2011
    Report Date
    October 19, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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. 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 DEVICE WAS RECEIVED INTACT FOR A MANUFACTURING EVALUATION AND PASSED FUNCTIONAL TESTING PER THE INSPECTION SHEET. VISUAL INSPECTION SHOWED NO ANOMALIES IN THE HOLE OR COLLAR DIAMETERS, DEPTHS OR RADII. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON CLOSED THE STERNUM IN AN OBESE PATIENT WITH TWO STEEL WIRES AND TWO STERNAL CABLES. WHEN WINDING THE FIRST CABLE AROUND THE WHEEL, THE CABLE BROKE. THE WHEEL HAD NOT YET BEEN ACTIVATED. THE SECOND CABLE BROKE AT THE FIRST ACTIVATION OF THE WHEEL. BOTH CABLES BROKE AT THE NOSE OF THE TENSIONING INSTRUMENT. THE SURGERY WAS CONTINUED WITH A NEW TENSIONER WITHOUT ANY PROBLEMS. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185583 TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 5888505

    Patients

    Seq Age Sex Outcome Treatment
    1