BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-MEDIUM FOR PEN DRIVE

    MDR report key: 3080580 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-11017
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING INVESTIGATION AND APPEARED TO BE DAMAGED. THE CUSTOMER COMPLAINT WAS VERIFIED AS THE ITEM WAS DAMAGED AND NOT REPAIRABLE. IT IS IMPOSSIBLE TO DETERMINE HOW THE PRODUCT WAS HANDLED OR CLEANED. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WISDOM TOOTH REMOVAL, THE SURGEON HAD DIFFICULTY FULLY SEATING AND REMOVING THE BURR FROM THE BURR ATTACHMENT PEN DRIVE. THE SURGEON NOTED THAT THE ATTACHMENT WAS HOT. ANOTHER HAND PIECE WAS USED TO COMPLETE THE CASE. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182215 BURR ATTACHMENT-MEDIUM FOR PEN DRIVE HWE SYNTHES GMBH 3338721

    Patients

    Seq Age Sex Outcome Treatment
    1