BEUDAMED
    FDA Adverse Event Other Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 1518459 · Received October 9, 2009

    Report

    Report Number
    1045254-2009-00046
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    May 29, 2009
    Report Date
    September 9, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WITH INCOMPLETE DATA WAS REC'D FROM THE USER FACILITY. THEIR INFO WAS NOT CONSISTENT WITH OUR RECORDS. FACILITY INITIALLY REPORTED THAT THE PRODUCT WAS RETURNED TO MEDTRONIC ON 07/19/09 AND OUR RECORDS INDICATE THE PRODUCT HAS NOT BEEN REC'D AS OF 10/09/09. SEVERAL ATTEMPTS WERE MADE TO HAVE THE PRODUCT RETURNED AND ON EACH OCCASION THE CUSTOMER STATED THEY STILL HAD POSSESSION OF THE PRODUCT AND WOULD RETURN THE SAMPLE. THIS PRODUCT WAS BEING USED FOR TREATMENT. THE PRODUCTS# COMPLAINT HISTORY INDICATES THAT THIS IS THE FIRST REPORT FOR THIS PRODUCT LOT. HISTORICALLY, THE ROOT CAUSE OF FRAGMENTS HAS BEEN DUE TO AN ERROR IN USAGE, SIDE LOADING OF THE DEVICE. THE DR STATED THAT THE BONE HE WAS CUTTING INTO WAS VERY HARD. THE INSTRUCTIONS FOR USE STATES: EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE. EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PT. UN-REMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PT. NO COMPLAINT TRENDS ARE INDICATED AT THIS TIME. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY. NO REMAINING INVENTORY OF THE REPORTED LOT NUMBER WAS AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    TWO BURS BROKE OFF DURING DRILLING OF THE FRONTAL SINUS. A FLUOROSCOPE WAS USED TO LOCATE THE FRAGMENTS, AND THEY WERE REMOVED VIA THE SINUS. NO FRAGMENTS REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG 77EQJ EQJ MEDTRONIC XOMED, INC. 1883672HS 56306500

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention