BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE KNEE INSTRUMENT

    MDR report key: 1170811 · Received September 15, 2008

    Report

    Report Number
    1644408-2008-00317
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 11, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE TIBIAL PLATE PIN GOT STUCK INSIDE THE PIN EXTRACTOR. ENCORE SALES REP WAS PRESENT AT THE SURGERY AND COMMENTED THAT THE PIN DID NOT LOOK LIKE AN ENCORE PIN. THE SURGICAL TECH CHECKED THE PIN IN THE GUIDE AND IT FIT, SO THEY PROCEEDED WITH SURGERY. WHEN THE DR WENT TO REMOVE THE PIN, IT WOULD NOT RELEASE FROM THE EXTRACTOR. THE DR WAS ABLE TO REMOVE ALL OF THE PINS FROM THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE KNEE INSTRUMENT PIN EXTRACTOR HWB ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other