BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3142339 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02595
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    March 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NO DEVIATIONS FROM THE SPECIFICATIONS. THE VISUAL INSPECTION OF THE CONTENDED SPIRAL DRILL SHOWED THAT THE TIP IS WITHDRAWN DUE TO MOMENTARY OVERLOAD. THE CAUSE OF THE OVERLOAD CANNOT BE CLEARLY ESTABLISHED. IT IS POSSIBLE THAT DUE TO AN UNINTENTIONAL BENDING MOMENT, OR IN CONTACT WITH METAL (GUIDING WIRE), THE LOAD CAPACITY OF THE MATERIAL WAS EXCEEDED AND EVENTUALLY LED TO THE BREAK. A REVIEW OF THE MATERIALS AND THE MANUFACTURING DOCUMENTATION REVEALED NO DEVIATIONS FROM THE SPECIFICATIONS. THE INVESTIGATION CONCLUDED THIS EVENT TO BE INVALID. ADDITIONAL COMMON DEVICE NAME HSZ, GFA, GFF.

    Description of Event or Problem · 1

    DRILL BROKE DURING SURGERY. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243227 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH 424091

    Patients

    Seq Age Sex Outcome Treatment
    1