BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXNEURO INSTRUMENT MODULE

    MDR report key: 6011748 · Received October 7, 2016

    Report

    Report Number
    2520274-2016-14836
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT. (B)(4) LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    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 THE CLIPS ON THE SIDE OF THE MATRIXNEURO COMPACT MODULE AND THE CLIPS ON THE SIDE OF THE MATRIXNEURO INSTRUMENT MODULE ARE BROKEN; THE MODULES LOCK TOGETHER TO MAKE A TRAY. THE LEG CLIPS ON THE COMPACT MODULE AND THE RECEIVING ARM CLIPS ON THE INSTRUMENT MODULE BROKE AT THE JUNCTION THAT HOLDS THE TWO MODULES TOGETHER. THE MODULES WILL NOT LOCK TOGETHER AND TAPE WAS BEING USED TO HOLD THE MODULES TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663450 MATRIXNEURO INSTRUMENT MODULE TRAY, SURGICAL INSTRUMENT FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1