BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3173937 · Received June 17, 2013

    Report

    Report Number
    1719045-2013-01644
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED DEVICE BY THE DEVELOPMENT ENGINEER LET US ASSUME THAT THE TENSIONER WAS NOT OPENED COMPLETELY BEFORE INSERTING THE WIRE. THEREFORE THE WIRE GOT JAMMED DURING INSERTION. IT IS IMPORTANT TO TURN THE NUT COMPLETELY BEFORE USE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION FINDINGS REVEALED THAT THE TENSIONER WAS NOT OPENED COMPLETELY BEFORE INSERTING THE WIRE AND THE CABLE GOT JAMMED DURING INSERTION. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. IT IS NOTED THAT DUE TO ONGOING PROBLEMS WITH THIS DEVICE IN THE FIELD, WE DECIDED TO DEVELOP A NEW DESIGNED INSTRUMENT AND THIS NEW VERSION OF THE CABLE TENSIONER IS NOW AVAILABLE.

    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. THE DEVICE LISTED IN THIS REPORT IS 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 SURGEON USED THE CABLE SYSTEM FOR TREATMENT AND WHEN THE CABLE WAS TIGHTENED THE CABLE TENSIONER RAN IDLE WITH THE CABLE BLOCKED INSIDE. THE CABLE COULD NOT BE TIGHTENED PROPERLY. THE INSIDE OF THE CABLE TENSIONER WAS WASHED FOLLOWING THE CLEANING MANUAL INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274472 CABLE TENSIONER LXH SYNTHES MONUMENT P053503

    Patients

    Seq Age Sex Outcome Treatment
    1