BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL/PCL MODULAR SYSTEM

    MDR report key: 1052638 · Received May 23, 2008

    Report

    Report Number
    2027970-2008-00010
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: FRACTURING WAS INITIATED BY A COMBINATION OF TORSIONAL & BENDING OVERLOAD. WHEN THE KNEE IS FLEXED MORE THAN RECOMMENDED IN THE SURGICAL TECHNIQUE, THE INSTRUMENT TIP GAS THE POTENTIAL TO BEND AND FATIGUE. UPON CLEANING AND USE IN THE NEXT SURGERY IT MAY BE BENT BACK INTO PROPER SHAPE. CONTINUED USE IN THIS MANOR WEAKENS THE TIP WHICH MAY CAUSE FATIGUE AND BREAKAGE.

    Description of Event or Problem · 1

    THE TIP OF THE AIMER FRACTURED AND SEPARATED IN THE PATIENT'S KNEE WHILE POSITIONING. THE SURGERY WAS EXTENDED APPROXIMATELY 40 MINUTES IN ORDER TO LOCATE AND REMOVE THE FOREIGN BODY. THE PATIENT SUFFERED NO ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL/PCL MODULAR SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET SPORTS MEDICINE 909627 L186610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other