BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONECUTTER

    MDR report key: 2700789 · Received August 15, 2012

    Report

    Report Number
    1219602-2012-00218
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 26, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC ENDOSCOPY DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT, SURGEON INDICATES: DURING ARTHROSCOPIC PROCEDURES BITS OF METAL SHAVINGS CAME OFF DISPOSABLE SHAVER DURING PROCEDURE. METAL WAS IDENTIFIED POST PROCEDURE MRI DURING POST OP OFFICE VISIT. SURGEON DID NOT IDENTIFY SPECIFIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONECUTTER BOXED F/R,BL,4.5MM,SERIES 3000 HAB SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7206011 50657339

    Patients

    Seq Age Sex Outcome Treatment
    1