BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR FOR CERCLAGE PASSER

    MDR report key: 3930074 · Received July 11, 2014

    Report

    Report Number
    2520274-2014-12504
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TROCAR WAS SLID INTO THE CERCLAGE PASSER AND WHEN THE SURGEON WENT TO REMOVE IT, IT SNAPPED BEING LEFT IN THE CERCLAGE PASSER. SOME COCKERS WERE USED TO PULL IT OUT. THERE WAS NO REPORTED IMPACT TO PATIENT. THERE WAS A ONE MINUTE DELAY IN THE SURGERY. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406685 TROCAR FOR CERCLAGE PASSER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1