BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCUT MAYO SCS 6-3/4 STR

    MDR report key: 1592696 · Received January 28, 2010

    Report

    Report Number
    2430952-2010-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS
    Product Code
    HFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHILE DOING A REPAIR OF AN ACL THE BLACK RUBBED OFF OF THE HANDLE ONTO THE SURGEONS GLOVED HANDS AND DESTROYED THE POSTERIOR TIBIAL TENDON GRAFT THAT THEY WERE INTERESTING. THE GRAFT HAD TO BE DISCARDED AND THERE WAS ANOTHER GRAFT AVAILABLE FOR USE. NO MORE THAN A 5-10 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERCUT MAYO SCS 6-3/4 STR NA HFG J. JAMNER SURGICAL INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1