BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER STABLECUT OSC FLAT MI 2K BLADE

    MDR report key: 1387725 · Received May 20, 2009

    Report

    Report Number
    1825034-2009-00093
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    April 8, 2009
    Report Date
    April 21, 2009
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. REVIEW OF THE STERILIZATION CERTIFICATION FOUND THAT LOT WAS STERILE RELEASED IN 2009. THE PRODUCT WAS MANUFACTURED BY SYNVASIVE TECHNOLOGY, INC. AND DISTRIBUTED BY ANOTHER CO.

    Additional Manufacturer Narrative · 1

    THE COMPONENT WAS FORWARDED TO MANUFACTURER/SUPPLIER, SYNVASIVE TECHNOLOGY, IN 2009 FOR EVALUATION. A REPORT WITH THE INVESTIGATION FINDINGS FROM SYNVASIVE WAS FORWARDED TO BIOMET A WEEK LATER. EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE ROOT CAUSE OF THE FRACTURE COULD BE ATTRIBUTED TO MISUSE OR STRIKING A METAL OBJECT. CORRECTION - REVIEW OF RECEIVING CERTIFICATION FOUND THAT LOT WAS STERILE RELEASED ON OCTOBER 29, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2009. SUBSEQUENTLY, THE POST-OPERATIVE RADIOGRAPHS REVEALED A FOREIGN BODY IN THE TIBIA. THE SURGEON NOTICED THAT THE BLADE OF THE MIK BLADE WAS FRACTURED AND BELIEVES THAT THIS MAY HAVE OCCURRED AS A RESULT OF CONTACT WITH A RETRACTOR. THIS WENT UNNOTICED DURING THE SURGERY. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2009. SUBSEQUENTLY, THE POST-OPERATIVE RADIOGRAPHS REVEALED A FOREIGN BODY IN THE TIBIA. THE SURGEON NOTICED THAT THE BLADE OF THE MIK BLADE WAS FRACTURED AND BELIEVES THAT THIS MAY HAVE OCCURRED AS A RESULT OF CONTACT WITH A RETRACTOR. THIS WENT UNNOTICED DURING THE SURGERY. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER STABLECUT OSC FLAT MI 2K BLADE BLADE, INSTRUMENT GFA BIOMET ORTHOPEDICS N/A 98W215

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R