BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER WITH PISTOL GRIP

    MDR report key: 3892265 · Received June 24, 2014

    Report

    Report Number
    1719045-2014-10279
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. 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

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE REPORTED BARREL WAS BLOCKED. THE REPAIR TECHNICIAN REPORTED THE CANNULATION HAD DIRT/DEBRIS INSIDE. DIRTY / DEBRIS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON JUNE 11, 2014. THIS ITEM PASSED SYNTHES FINAL INSPECTION AND WAS RETURNED TO THE CUSTOMER ON JULY 10, 2014. 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 THE BARREL ON THE CABLE TENSIONER WAS BLOCKED. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368576 CABLE TENSIONER WITH PISTOL GRIP MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P159750

    Patients

    Seq Age Sex Outcome Treatment
    1