BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0

    MDR report key: 3171576 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01551
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 23, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ALL THREE DRILL BITS SHOWED SEVERE DAMAGE AT THE DRILL BIT TIP. THE MACROSCOPIC ASSESSMENT SHOWED AN UNTWISTED SHAFT AS WELL AS PARTIALLY MELTED DRILL BIT TIP. THE OBSERVED DEFORMATIONS, ABRASIONS AS WELL AS THE DISCOLORATIONS OF THE DRILL BIT TIPS ARE CLEAR INDICATIONS OF OVERSTRAINING THE DRILL BIT MATERIAL WHICH WAS MOST LIKELY CAUSED BY ONE OR A COMBINATION OF THE FOLLOWING CONDITIONS: INCREASED FRICTION AT THE CUTTING ZONE, HIGH SPEED DRILLING, AND CONTACT WITH HIGH DENSE MATERIAL E.G. METALLIC MATERIALS, TO LESS IRRIGATION, BLUNT CUTTING TINES.

    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. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DRILL BIT TIP OVERHEATED DURING USAGE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272597 MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0 HTW SYNTHES MONUMENT U117137

    Patients

    Seq Age Sex Outcome Treatment
    1