BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R-C 8MM

    MDR report key: 470562 · Received July 7, 2003

    Report

    Report Number
    MW1028911
    Event Type
    Malfunction
    Date Received
    July 7, 2003
    Date of Event
    June 17, 2003
    Report Date
    June 24, 2003
    Manufacturer
    LENOX MACLAREN
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/19/03: REPAIR REQUEST: SURGEON REQUESTED REPLACEMENT WITH NEW INSTRUMENT. IMPROPER USE: INSTRUMENT APPEARS TO HAVE BEEN OVER POWERED BY USER. THIS INSTRUMENT WAS MADE AS A SPECIAL REQUEST FROM THE SURGEON. AS CO WAS NOT ALLOWED TO EVALUATE THE PHYSICAL INSTRUMENT. IT IS UNABLE TO DETERMINE THE USE, OR SHARPENING HISTORY. THE INSTRUMENT APPEARS FROM THE PHOTO COPY THAT THE DELICATE TIP WAS OVER POWERED BY THE USER. PLEASE NOTE THAT THIS IS A CUSTOM-MADE DEVICE FOR THE INDIVIDUAL SURGEON.

    Description of Event or Problem · 1

    THE PT WAS DIAGNOSED WITH PROGRESSIVE, SEVERE L5 RADICULOPATHY AND WAS UNDERGOING SPINAL SURGERY IN 2003. DURING THE PROCEDURE, THE SURGEON NOTED THAT, WHILE USING THE ANGLED RING CURETTE, ITS TIP "SNAPPED" OFF, BUT HE WAS ABLE TO RETRIEVE THE FRAGMENTS. NO REMNANT OF THE DEFECTIVE INSTRUMENT REMAINED IN THE SURGICAL WOUND. THE PT WAS NOT PLACED AT RISK OF HARM, NOR WAS THE LENGTH OF THE SURGERY EXTENDED BECAUSE OF THIS EVENT. THE DEFECTIVE INSTRUMENT AND ITS LOOSE FRAGMENTS (ABOUT 3/4 -INCH IN LENGTH) WERE SENT TO RISK MANAGEMENT FOR SAFEKEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R-C 8MM RING CURETTE (ANGLED) FZS LENOX MACLAREN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR