BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5755712 · Received June 28, 2016

    Report

    Report Number
    1719045-2016-10520
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION EVALUATION: ONE (1) CABLE TENSIONER (PART: 391.201 / LOT: P082571) WAS RECEIVED WITH A CABLE LODGED IN THE CHUCK JAWS. ADDITIONAL INSPECTIONS, INCLUDING DESTRUCTIVE TESTING ON THIS DEVICE, YIELDED THE FOLLOWING RESULTS: THE TENSIONER WAS DISASSEMBLED AND IT WAS FOUND THAT THE COMPRESSION SPRING WITHIN THE COLLET ASSEMBLY, WHICH IS REQUIRED TO OPEN THE COLLET JAWS, DID NOT RETURN TO ITS ORIGINAL LENGTH. WHEN THE COLLET JAWS ARE UNABLE TO BE FULLY OPENED, IT CAUSES THE CABLE TO FRAY AND BECOME CAUGHT WITHIN THE TENSIONER. THE FRAYED CABLE WAS LODGED BETWEEN THE COLLET TIPS. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. THE ORIGINAL AWARENESS DATE FOR THE REPORTED EVENT WAS POPULATED AS JUNE 15, 2016 IN ERROR ON THE INITIAL MEDWATCH. THE ACTUAL AWARENESS DATE FOR THE EVENT WAS JUNE 14, 2016. DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE AND REPAIR HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE (CABLE TENSIONER, PART NUMBER 391.201, LOT NUMBER P082571) BUT COULD NOT BE COMPLETED BECAUSE THE DEVICE IS A LOT/BATCH CONTROLLED ITEM. THE SERVICE HISTORY IS THEREFORE, UNCONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE DATE OF MANUFACTURE IS DEC 6, 2010. THE SUBJECT DEVICE IS CURRENTLY IN THE EVALUATION PROCESS AND THE RESULTS ARE PENDING COMPLETION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AND WEIGHT WERE NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED. 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 PERIPROSTHETIC PROXIMAL FEMUR REVISION SURGERY, FOR A FRACTURE FEMUR BELOW THE HIP STEM, THE 1.7MM CABLE GOT BOUND UP AND STUCK IN THE CABLE TENSIONER BECAUSE OF THE SLACK IN THE TENSIONER. THE TENSIONER WOULD NOT TIGHTEN PROPERLY. THE TENSIONER AND CABLE REMAINED STUCK TOGETHER AND WERE SENT TO STERILE PROCESSING. DEVICES WERE IMPLANTED DURING THIS PROCEDURE AND NO DEVICES WERE EXPLANTED. THERE WAS A SURGICAL DELAY OF TWO MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409883 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P082571

    Patients

    Seq Age Sex Outcome Treatment
    1