BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 W/STOP L44.5/12 2FLUTE

    MDR report key: 2937314 · Received January 31, 2013

    Report

    Report Number
    8030965-2013-00259
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEASURABLE DIMENSION OF THE BROKEN DRILL BIT WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE CROSS SECTION SURFACES SHOW NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. PMA/501(K)# SHOULD BE K962913.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING 2 DRILL BITS THAT BROKE DURING A PROCEDURE TO TREAT A PATIENT WITH A MANDIBULAR SYMPHYSIS FRACTURE. DURING DRILLING OF THE MANDIBLE BODY, TWO DRILL BITS WERE BROKEN LEAVING A TIP IN THE BONE OF THE JAW. THE SURGEON DECIDED TO LEAVE THE DRILL BIT FRAGMENT IN THE JAW, REPORTEDLY WITHOUT ADVERSE EFFECT AT TIME OF SURGERY. THIS IS REPORT # 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43681 DRILL BIT Ø1.5 W/STOP L44.5/12 2FLUTE DRILL BIT HTW SYNTHES GMBH F-11666

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR