BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 L45/33 2FLUTE

    MDR report key: 3181242 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03756
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE MEASURABLE DIMENSIONS OF THE DRILL BIT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. THE VISUAL INSPECTION AND INVESTIGATION OF THE DEVICE FOUND THAT THE CUTTING EDGES ABOVE THE FRACTURE WERE BLUNT. IT IS POSSIBLE THAT AN EXCESSIVE METALLIC CONTACT IN COMBINATION WITH TOO MUCH LATERAL STRESS CAUSED THIS BREAKAGE. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. ADDITIONAL COMMON DEVICE NAMES: HSZ, GFA, GFF. (B)(6).

    Description of Event or Problem · 1

    THE DRILL BIT BROKE DURING THE OPERATION. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282810 DRILL BIT Ø1.1 L45/33 2FLUTE HWE SYNTHES GMBH 424267

    Patients

    Seq Age Sex Outcome Treatment
    1