BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5567441 · Received April 11, 2016

    Report

    Report Number
    1719045-2016-10306
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Report Date
    March 18, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). PART 391.201, LOT P222879: RELEASE TO WAREHOUSE DATE: (B)(6) 2015. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PRODUCT INVESTIGATION SUMMARY: THE INVESTIGATION OF THE RETURNED DEVICE HAS SHOWN THAT THE CABLE TENSIONER IS COMPLETELY JAMMED. ALSO, THE DEVICE SHOWS THAT SEVERAL CORDS ARE VISIBLY JAMMED IN THE GRIPPING MECHANISM (CLAMPING JAWS). WHEN THE DEVICE IS TURNED COUNTERCLOCKWISE AT THE FLUTED KNOB AT THE END OF THE TENSIONER, THE CABLE COULD, WITH LESS FORCE, BE REMOVED FROM THE TENSIONER. THE MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE OCCURRENCE WAS LIKELY CAUSED BY AN INCORRECT MANIPULATION OF THE DEVICE. PLEASE NOTE: INSTRUCTIONS FOR USE TELL THE USER TO TURN THE FLUTED KNOB AT THE END OF THE TENSIONER COUNTERCLOCKWISE AS FAR AS POSSIBLE RENDERING INSERTION / REMOVAL. THE NEW DESIGN IS ALREADY AVAILABLE FROM STOCK WITH THE NEW PRODUCT NUMBER 03.221.015. NO INDICATION FOR PRODUCT RELATED ISSUES WERE FOUND. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CABLE CANNOT BE REMOVED FROM A CABLE TENSIONER. FAILURE WAS DETECTED DURING CLEANING PROCESS. DATE OF EVENT UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE HAPPENED POST-OPERATIVELY. THEREFORE NO PROLONGATION OR DELAY OF SURGERY CAUSED. ADDITIONALLY, A TROCAR WAS RECEIVED WITH THE HANDLE BROKEN OFF. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222894 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P222879

    Patients

    Seq Age Sex Outcome Treatment
    1