BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø3.2 CALIBR L474 3FLUTE F/HIPS

    MDR report key: 3161297 · Received June 11, 2013

    Report

    Report Number
    1719045-2013-01534
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    September 20, 2011
    Report Date
    October 10, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE DRILL BIT IS BROKEN. THE MEASURABLE DIMENSIONS OF THE BROKEN DRILL BIT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY AS WELL. WE ASSUME THAT TOO HIGH MECHANICAL FORCE IN A SLANTING DIRECTION MAY HAVE CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MULTI TRAUMA, INVOLVING A (B)(6) WITH BILATERAL FEMORAL FRACTURES, THE CALIBRATED HOP SCREW DRILL BIT BROKE OFF INSITU AT THE JUNCTION OF THE MOST DISTAL CHANGE OF SIZE OF THE DRILL BIT. THE BROKEN DRILL BIT WAS RETRIEVED AT THE END OF THE CASE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263147 DRILL BIT Ø3.2 CALIBR L474 3FLUTE F/HIPS HTW SYNTHES MONUMENT US99067

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR