BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH 14MM STOPQC

    MDR report key: 3063759 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10897
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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 MANUFACTURING EVALUATION SHOWED THAT THE TIP OF THE DRILL BIT IS BROKEN OFF. OUR INVESTIGATION HAS SHOWN THAT THE CUTTING EDGES OFF THE BROKEN TIP ARE COMPLETELY BLUNT. ALSO, IT WAS FOUND THAT THERE ARE HEAVY STRESS MARKS AT THE SHAFT ABOVE THE DRILL BIT AND IT IS CLEARLY VISIBLE THAT THE DRILL BIT WAS BENT BEFORE IT BROKE. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THESE FINDINGS LET US ASSUME THAT AN EXCESSIVE METALLIC CONTACT IN COMBINATION WITH TOO MUCH LATERAL STRESS CAUSED THE BREAKAGE OF THIS DEVICE. IT IS CONCLUDED THAT NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON WAS USING THE 2.0 MM DRILL BIT WITH 14MM STOP AND IT BROKE. THE SURGEON RETRIEVED ALL PIECES, AND THE PROCEDURE WAS COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164712 2.0MM DRILL BIT WITH 14MM STOPQC OVE SYNTHES GMBH 2775410

    Patients

    Seq Age Sex Outcome Treatment
    1