BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTISKNEE CUTTING GUIDE - STRYKER

    MDR report key: 1624835 · Received February 19, 2010

    Report

    Report Number
    3005738134-2010-00052
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    July 21, 2009
    Report Date
    February 10, 2010
    Manufacturer
    OTISMED CORP
    Product Code
    OOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SEGMENTATION REVIEW, PLANNING REVIEW, JIG DESIGN REVIEW. RESULTS: SEGMENTATION REVIEW: PERFORMED TO SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. PLANNING REVIEW: PERFORMED TO SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. JIG DESIGN REVIEW: GUIDES MANUFACTURED TO SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. CONCLUSION: NO CONCLUSION CAN BE DETERMINED DUE TO LACK OF INFO. DEVICE WAS NOT RETURNED. REVIEW INDICATES EVERYTHING IS ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    FEMORAL GUIDE FLOATED TODAY WITH EXCESSIVE POSTERIOR BONE REMOVAL, MEDIAL GREATER THAN LATERAL, THAT REQUIRED CHANGING THE ROTATION OF THE FEMORAL COMPONENT TO MORE INTERNALLY ROTATED. BONE RESECTION THICKNESSES ARE INDICATED IN PRE-OP PLAN (POP) WITH FOLLOWING CODE DM 5MM, PM 12MM, DL 8MM, PL 9MM. PT WAS PLANNED WITH 2.5MM RULE SO THE CUTS SHOULD HAVE BEEN 7.5MM THICK FROM THE FEMORAL COMPONENT BEING TRANSLATED PROXIMAL AND ANTERIOR. THE 7.5MM RESECTION PLUS 1.5 KERF FROM SAY BLADE 1MM FOR TRANSLATION EQUALS 8MM WHICH IS THE THICKNESS OF THE TRIATHLON FEMORAL COMPONENT. THE EXCESSIVE POSTERIOR CUT THAT WAS MEDIAL GREATER THAN LATERAL SUGGESTS THE FEMORAL GUIDE LOCKED IN TOO MUCH IR (ABOUT 3 DEGREES) AND TRANSLATED ANTERIOR 1.5 FROM THE INTENDED POSITION. THE MALROTATION OF THE FEMORAL GUIDE SEEMED TO PIVOT ON THE LATERAL PIN RATHER THAN THE CENTER OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTISKNEE CUTTING GUIDE - STRYKER NONE OOG OTISMED CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other