BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA.

    MDR report key: 2081779 · Received April 14, 2011

    Report

    Report Number
    2249697-2011-00475
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A MFG NON-CONFORMANCE WAS OBSERVED BASED ON VISUAL INSPECTION WHICH INDICATED THAT THE FIXATION PEG(S) DISASSOCIATED FROM THE POSTERIOR FACE OF THE TRIATHLON CUTTING BLOCK. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THIS EVENT IS RELATED TO A TREND OF SIMILAR EVENTS WHERE THE FIXATION PEG(S) HAS DISASSOCIATED FROM THE POSTERIOR FACE OF THE TRIATHLON CUTTING BLOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED: "SMALL PIN ON BACK OF CUTTING BLOCK, BROKE OFF BLOCK AS IT WAS BEING EXTRACTED FROM PT'S KNEE. THE PIN WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SB3A06

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other