BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #5 4:1 CUTTING BLOCK

    MDR report key: 2941877 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00545
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EVENT WAS CONFIRMED. THE DEVICE IS NON-FUNCTIONAL. THE INVESTIGATION CONCLUDED THAT THERE WAS AN INDENTATION OF SIGNIFICANT SIZE ON THE TOP LEFT SIDE OF THE CUTTING BLOCK. THIS INDENTATION CAUSED A PROTUBERANCE THAT INTERFERED WITH THE FLATNESS OF THE ASSOCIATED SURFACE AND PROPER ASSEMBLY OF THE MODULAR CAPTURE. THE INDENTATION LIKELY OCCURRED DURING USE. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    RIGHT ANTERIOR PORTION OF #5 TRIATHLON 4:1 FEMORAL CUTTING BLOCK ((B)(4)) WAS PREVENTING THE MODULAR CAPTURE FROM PURCHASING EASILY. AFTER THE CAPTURE WAS ATTACHED, THE .050 SAWBLADE WOULD NOT GLIDE THROUGH THE SLOT ANTEROLATERALLY (RIGHT KNEE). THE SURGEON PROCEEDED WITH HIS TIBIAL CUT PREP, AND DECIDED TO DROP TO A #4 FEMORAL 4:1 BLOCK, AND AFTER CHECKING HIS ANTERIOR FEMORAL CLEARANCE, USED A #4 BLOCK.

    Description of Event or Problem · 1

    RIGHT ANTERIOR PORTION OF #5 TRIATHLON 4:1 FEMORAL CUTTING BLOCK ((B)(4)) AS PREVENTING THE MODULAR CAPTURE FROM PURCHASING EASILY. AFTER THE CAPTURE WAS ATTACHED, THE .050 SAWBLADE WOULD NOT GLIDE THROUGH THE SLOT ANTEROLATERALLY (RIGHT KNEE). THE SURGEON PROCEEDED WITH HIS TIBIAL CUT PREP, AND DECIDED TO DROP TO A #4 FEMORAL 4:1 BLOCK, AND AFTER CHECKING HIS ANTERIOR FEMORAL CLEARANCE, USED A #4 BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46081 #5 4:1 CUTTING BLOCK INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SB1W03

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other