BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1974050 · Received December 28, 2010

    Report

    Report Number
    2249697-2010-01907
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    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

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2010-01904, 01905, 01906, 01908, 01909, 01910, 01911 & 01912.

    Description of Event or Problem · 1

    THE TRIATHLON EXPRESS CUTTING BLOCKS WERE SENT LOOSE IN A TRAY TO THE HOSPITAL AS THERE IS NO IDENTIFIED SPOT FOR THEM IN THE INSTRUMENT TRAY. THEY WERE STERILIZED IN A GREEN PLASTIC TRAY, HOWEVER, THE SPIKES ON THE CUTTING BLOCKS PIERCED THROUGH THE DRAPE WRAPPING MAKING THE TRAY & INSTRUMENTS UNSTERILE AND CAUSING THE CASE TO BE CANCELLED. THIS WAS IDENTIFIED WHILE UNWRAPPING/OPENING THE INSTRUMENTS SET IN THEATRE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention