BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM SMALL-JOINT AGGRESSIVE PLUS CUTTER, FORMULA

    MDR report key: 1013977 · Received March 11, 2008

    Report

    Report Number
    2648666-2008-00027
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 14, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHILE PERFORMING AN ANKLE SCOPE, THE CUTTING EDGE BROKE IN THE SHAFT. THE DOCTOR CLAIMS THAT HE WAS USING THE BLADE APPROPRIATELY AND WAS "DEAD CENTER IN THE JOINT." THE DOCTOR TRIED TO PULL IT OUT, BUT THE PIECE FELL TO THE BACK OF THE ANKLE JOINT. THEY TRIED TO GET IT OUT, BUT COULD NOT. THEY THEN TRIED TO USE THE ANGLED PARTS OF THE KNEE ARTHROSCOPY KIT TO TRY TO GRASP THE PIECE. WHEN THEY STILL COULD NOT RETRIEVE THE PIECE, THEY HAD TO MAKE AN EXTRA INCISION AT THE BACK OF THE ANKLE AND WERE FINALLY ABLE TO REMOVE THE BROKEN PIECE. THE INCIDENT CAUSED THE CASE TO EXTEND AN ADDITIONAL 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM SMALL-JOINT AGGRESSIVE PLUS CUTTER, FORMULA CUTTER FZT STRYKER ENDOSCOPY PUERTO RICO 07039CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK