BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4221165 · Received November 3, 2014

    Report

    Report Number
    1719045-2014-10551
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL MANUFACTURE DATE: FEBRUARY 3, 2009. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE CABLE TENSIONER, PART 391.201, AND LOT P038958. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND TO SYNTHES FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW: LOT P038958 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A MANUFACTURING EVALUATION WAS COMPLETED: VISUAL INSPECTION FOUND THAT THE CANTED COIL SPRING WITHIN THE TIP OF THE TENSIONER WAS MISSING. THIS COMPONENT IS CRUCIAL TO SECURING THE TENSIONER TO THE RETENSIONER. DIMENSIONAL INSPECTION CONFIRMED THAT THE SLOT FEATURE THAT HOUSES THE COIL SPRING MET SPECIFICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONFIRMED BUT IS NOT CONSIDERED MANUFACTURING-RELATED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE, THE SURGEON WAS NOT ABLE TO CLICK THE CABLE TENSIONER ONTO THE TENSION HOLDER. ANOTHER CABLE TENSIONER WAS READILY AVAILABLE AND USED WITH THE SAME TENSION HOLDER. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702476 CABLE TENSIONER MISC ORTHO SURG INSTRUMENTS LXH SYNTHES MONUMENT P038958

    Patients

    Seq Age Sex Outcome Treatment
    1