BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø17 CANN F/PFNA

    MDR report key: 3193636 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02950
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    September 22, 2011
    Report Date
    October 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MEASURABLE DIMENSION OF THE BROKEN DRILL BIT WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE 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. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES. WE FOUND THAT THE CUTTING EDGES ARE DAMAGED AND BLUNT. THIS LET US ASSUME, THAT A HEAVY EXCEEDING MECHANICAL OVERLOADING SITUATION IN LATERAL DIRECTION DURING DRILLING, MAY HAVE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DRILL BIT SHAFT BROKE OFF WHERE IT COUPLES TO THE POWERTOOLS JACOBS CHUCK ATTACHMENT DURING USE. A SYNTHES REPRESENTATIVE WAS IN ATTENDANCE; NO MISUSE WAS OBSERVED. THIS DRILL BIT IS THE ONLY ONE WITHIN THE SYSTEM WITHOUT A DHS COUPLING. THIS IS THE ONLY MEDULLARY NAIL REAMER WE SEE FAIL IN THIS MANNER IN WESTERN AUSTRALIA. THE END PIECE OF THE SHAFT REMAINING IN THE CHUCK ATTACHMENT WAS DISCARDED. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293316 DRILL BIT Ø17 CANN F/PFNA HTW SYNTHES GMBH SX401592

    Patients

    Seq Age Sex Outcome Treatment
    1