BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR ATTACHMENT ANGLED

    MDR report key: 2994067 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-10384
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    June 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MFG EVAL REPORTS THE SAMPLE WAS REC'D AND VISUAL INSPECTION NOTED CORROSION ON THE COLLET OF THE MILLING TOOL. FUNCTIONAL TESTING REVEALED RESISTANCE WHEN TOOL TURNED IN THE ATTACHMENT. THE RESISTANCE IS INDICATIVE THAT THE BEARINGS ARE WORN AND DIRTY THEREFORE RESULTING IN FRICTION THAT CAN CREATE HEATING DURING USAGE. THE APPEARANCE OF THE DEVICE POSSIBLY INDICATES A LACK OF DEVICE MAINTENANCE ALONG WITH INCORRECT REPROCESSING LEADING TO THE REPORTED MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT IS INDETERMINATE FROM A MFG PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USAGE THE ANGLED BURR ATTACHMENT IS HEATING AND BURNING SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84146 BURR ATTACHMENT ANGLED HWE SYNTHES GMBH 1430031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention