BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM MILLING BIT WITH

    MDR report key: 3001785 · Received February 11, 2013

    Report

    Report Number
    1719045-2013-10065
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. ORIGINAL AWARENESS DATE IS 03/11/2011.

    Description of Event or Problem · 0

    COMPLAINT# (B)(4).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. THE DHR WAS REVIEWED AND THE RECORD INDICATES THE PARTS WERE MANUFACTURED IN CONFORMANCE WITH SYNTHES SPECIFICATIONS. THERE WERE NO MRRS OR NCRS NOTED DURING THE DHR REVIEW. THERE WERE NO PREVIOUS COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE DHR REVIEW, AND THE EVALUATION, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    DURING A PRODISC-C (PDC) PROCEDURE C5-C6, C6-C7 THE SURGEON WAS DRILLING FOR THE KEEL AT C5-C6 LEVEL AND THE 2.0MM MILLING BIT BROKE IN HALF. THE SURGEON NOTED THAT HE USED A DRILL THAT DID NOT HAVE ENOUGH RPM'S. THERE WERE NO OTHER DRILLS AVAILABLE. THE SURGEON RETRIEVED THE TWO PIECES, IRRIGATED THE AREA, AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536448 2.0MM MILLING BIT WITH GFG SYNTHES (USA) MONUMENT 6344206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown