BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE

    MDR report key: 3183579 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-02865
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    July 3, 2012
    Report Date
    July 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 MICROSCOPIC VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES WHAT INDICATES MATERIAL CONFORMITY. SINCE WE ARE NOT AWARE OF THE EXACT CIRCUMSTANCES DURING THE OPERATION WE SUPPOSE THAT MECHANICAL OVERLOADING SITUATION MUST HAVE LED TO BREAKAGE. THE LOT IN QUESTION WAS PRODUCED IN APRIL 2006 AT A QUANTITY OF (B)(4) PIECES AND ALL HAVE BEEN DISTRIBUTED WORLDWIDE. PLEASE NOTE THAT WE HAVE NOT RECEIVED A SIMILAR COMPLAINT WITH THE LOT IN QUESTION SO FAR. NO PRODUCT FAULT COULD BE DETECTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NONE WERE LEFT IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284403 DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE HXX SYNTHES GMBH SX491954

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR