BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR PINS Ø3.2MM

    MDR report key: 3595888 · Received January 28, 2014

    Report

    Report Number
    2520274-2014-00334
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    August 21, 2013
    Report Date
    August 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE ITEM HAS NOT BEEN SENT IN FOR SERVICE. THE MANUFACTURE DATE IS UNKNOWN.(B)(4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MOQ: ADDITIONAL CODE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    (B)(6). DURING A TOTAL KNEE AND TOTAL HIP SURGICAL PROCEDURE, SURGEON STATED RESISTANCE WAS FELT WHEN LOADING THE PINS INTO THE PIN DRIVER. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61805 QUICK COUPLING FOR PINS Ø3.2MM GEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1