BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE REAMER 11MM

    MDR report key: 2240753 · Received September 9, 2011

    Report

    Report Number
    1220246-2011-00151
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. EVALUATION OF THE RETURNED BROKEN TIP OF THE REAMER REVEALED A FRACTURE WITH ROUGH SURFACE AND LITTLE DEFORMATION. DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. COMPLAINANT'S EVENT WAS MOST LIKELY CAUSED BY THE DEVICE BEING HIT AGAINST OTHER METAL DEVICES OR PRYING/LEVERAGING THE DEVICE DURING USE. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE ORIGINAL CASE WAS ON (B)(6) 2011. ON (B)(6) 2011 A POST OPERATIVE X-RAY REVEALED A 4MM FLUTE OF ARTHREX'S LOW PROFILE REAMER IN POSTERIOR ASPECT OF KNEE. ON (B)(6) 2011, X-RAY DONE, FLUTE APPEARED TO HAVE MOVED TO INTERCONDYLAR NOTCH. PATIENT INTERVENTION: (B)(6) 2011 ARTHROSCOPIC ASSISTED AND FLUOROSCOPIC GUIDED REMOVAL OF METAL FOREIGN BODY PERFORMED. CONFIRMED METAL OBJECT: LOW PROFILE FLUTE. STATED DEVICE WAS NOT REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE REAMER 11MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other